Retin-A Micro

Description for Retin-A Micro

Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C₂₀H₂₈O₂ and the following chemical structure:

RETIN-A MICRO (tretinoin) gel is for topical use. Each gram of RETIN-A MICRO gel:

• 04%, contains 0.4 mg of tretinoin
• 0.06%, contains 0.6 mg of tretinoin
• 08%, contains 0.8 mg of tretinoin
• 1%, contains 1 mg of tretinoin

The formulation contains methyl methacrylate/glycol dimethacrylate crosspolymer (MICROSPONGE^® System), propylene glycol dicaprylate/dicaprate and butylated hydroxytoluene. Other components consist of benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, purified water, sorbic acid, and trolamine.

INDICATIONS AND USAGE

RETIN-A MICRO^® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

Dosage for Retin-A Micro

For topical use only. Not for oral, ophthalmic, or intravaginal use.

• Prior to RETIN-A MICRO use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry.
• When applying RETIN-A MICRO, keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.
• Apply a thin layer of RETIN-A MICRO (0.04%, 0.06%, 0.08%, or 0.1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening. Do not apply more than a thin layer [see Warning and Precautions (5.1)].

Improvements in acne lesions may be noticed after two weeks of RETIN-A MICRO therapy, but more than seven weeks of therapy may be needed for sustained benefit.

If RETIN-A MICRO was temporarily discontinued due to local adverse reactions, RETIN-A MICRO therapy may be resumed upon resolution of local adverse reactions.

HOW SUPPLIED

Dosage Forms And Strengths

Gel (white to very pale yellow and opaque):

• 04% (0.4 mg of tretinoin per gram) • 0.06% (0.6 mg of tretinoin per gram)
• 08% (0.8 mg of tretinoin per gram)
• 1% (1 mg of tretinoin per gram).

How Supplied

RETIN-A MICRO (tretinoin) gel is opaque and white to very pale yellow in color and is supplied as follows:

Strength	Amount of Tretinoin in One Gram of Gel	Quantity/Package Type	NDC
0.04%	0.4 mg	20 gram tube	0187-5144-20
		45 gram tube	0187-5144-45
		50 gram pump	0187-5144-50
0.06%	0.6 mg	50 gram pump	0187-5146-50
0.08%	0.8 mg	50 gram pump	0187-5148-50
0.1%	1 mg	20 gram tube	0187-5140-20
		45 gram tube	0187-5140-45
		50 gram pump	0187-5140-50

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Store pump upright.

Distributed by:Bausch Health US, LLC Bridgewater, NJ 08807 USA

Warnings for Retin-A Micro

Included as part of the PRECAUTIONS section.

Precautions for Retin-A Micro

Local Skin Irritation

RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging [see Adverse Reactions (6.1)]. Use of RETIN-A MICRO in greater than the recommended dosage (more frequent than once daily application or excessive application) will not result in more rapid or improved acne results and may result in marked redness, peeling, or discomfort.

Tretinoin has been reported to cause severe local skin irritation on eczematous skin.

Weather extremes, such as severe wind or cold, may increase the risk of skin irritation in patients using RETINA MICRO.

To reduce the risk of local skin irritation, instruct RETIN-A MICRO-treated patients to:

• Avoid use of RETIN-A MICRO in areas affected by eczema.
• Minimize or avoid use of RETIN-A MICRO with weather extremes.
• Wash the treated skin gently, using a mild, non-medicated soap, pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing. RETIN-A MICRO is not recommended with concomitant use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, or lime peels.
• Apply a topical moisturizer.

Advise patients that concomitant use of topical over the counter (OTC) acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO may increase the risk for local skin irritation including dryness, erythema, and peeling. Consider withholding the use of topical OTC acne products if signs of skin irritation develop. Advise patients to allow the skin irritation effects of the topical OTC acne products to subside before initiation of RETIN-A MICRO treatment.

If severe local skin irritation occurs, discontinue RETIN-A MICRO use temporarily or permanently.

Efficacy of RETIN-A MICRO at reduced frequencies of application has not been established.

Initial Worsening of Inflammatory Acne Vulgaris

During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory acne vulgaris lesions may occur. If RETIN-A MICRO is tolerated, initial worsening of inflammatory acne vulgaris lesions should not be considered a reason to discontinue therapy.

Photosensitivity

RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using RETIN-A MICRO. Advise patients with sunburn to not use RETIN-A MICRO until the sunburn fully recovers. 

Advise patients, especially those who may be required to have extended periods of UV light exposure (e.g., due to occupation or sports), those with inherent sensitivity to the sun, or those using drugs that cause photosensitivity, to use sun protection daily in the form of sunscreen (sun protection factor [SPF] ≥ 15) and sunprotective clothing, when UV exposure cannot be avoided, even on days when it is not sunny or inside activities are expected.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies with pregnant rats, alterations in the vertebrae and ribs of offspring were observed with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 5 to 10 times the maximum recommended human dose (MRHD). In animal reproduction studies with pregnant rabbits, fetal malformations, such as domed head and hydrocephaly, were observed in the offspring with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 10 to 19 times the MRHD.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.

Data

Human Data: Published data from prospective observational studies and retrospective cohort studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including potential misclassification of exposure, small sample size and in some cases, lack of physical exam by an expert in birth defects.

Animal Data: For purposes of comparison of the animal exposure to systemic human exposure, the MRHD applied topically is defined as 1 gram of Retin-A Micro (tretinoin) Gel microsphere, 0.1%, applied daily to a 60 kg person (0.017 mg tretinoin/kg body weight).

• Pregnant rats were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 6-15. Alterations were seen in the vertebrae and ribs of the affected offsprings at 0.5 mg/kg/day tretinoin, 5 to 10 times the MRHD based on body surface area (BSA) comparison.
• Pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 7-19. Doses were administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. Increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species were observed at doses of 0.5 and 1 mg/kg/day. Similar malformations were not observed in the offspring at 0.2 mg/kg/day, 4 times the MRHD based on BSA comparison.
• In a second rabbit study, pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.5 or 1 mg/kg/day tretinoin on gestation days 7-19. Doses were administered topically for six hours per day while pregnant rabbits were restrained in stocks to prevent ingestion. The offspring of pregnant rabbits exposed to 0.5 or 1 mg/kg/day tretinoin did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the MRHD based on BSA comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the MRHD based on BSA comparison).
• Malformations (shortened or kinked tail) were observed in the offspring of pregnant rats treated with topical tretinoin at doses greater than 1 mg/kg/day during the period of organogenesis (10 times the MRHD based on BSA comparison).
• Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported in offspring when 10 mg/kg/day was topically applied to pregnant rats during the period of organogenesis.
• Supernumerary ribs have been a consistent finding in newborn rats when dams were treated topically or orally with retinoids.
• Oral administration of tretinoin during organogenesis has been shown to cause malformations in the offspring of rats, mice, rabbits, hamsters, and nonhuman primates. Fetal malformations and death were observed when tretinoin was orally administered to pregnant rats during organogenesis at doses greater than 1 mg/kg/day (10 times the MRHD based on BSA comparison).
• Fetal malformations were reported at doses of 10 mg/kg/day or greater when administered to pregnant cynomolgus monkeys, but none were observed at 5 mg/kg/day (95 times the MRHD based on BSA comparison), although increased skeletal variations were observed at all doses. Dose-dependent increases in embryolethality and abortion also were reported.
• In peri- and postnatal development studies in rats with oral tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (19 times the MRHD based on BSA comparison).
• Oral tretinoin has been shown to be fetotoxic in rats when administered at doses 24 times the MRHD based on BSA comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 10 times the MRHD based on BSA comparison.

Lactation

Risk Summary

There are no data on the presence of tretinoin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of tretinoin could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for RETIN-A MICRO and any potential adverse effects on the breastfed infant from the RETIN-A MICRO or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the infant via human milk, during breastfeeding, use RETIN-A MICRO on the smallest area of skin with acne and for the shortest duration possible. Advise breastfeeding women not to apply RETIN-A MICRO directly to the nipple and areola to avoid direct infant exposure.

Pediatric Use

The safety and effectiveness of RETIN-A MICRO for topical application for the treatment of acne vulgaris have been established in pediatric patients aged 12 years and older. The safety and effectiveness of RETIN-A MICRO have not been established in pediatric patients younger than 12 years of age.

Geriatric Use

Clinical trials of RETIN-A MICRO did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger adult subjects. Acne vulgaris is largely a disease of pediatric and young adult patients. Clinical studies of RETIN-A MICRO did not include patients 65 years of age and older.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dermal carcinogenicity testing has not been performed with RETIN-A MICRO (tretinoin) gel microsphere, 0.04%, 0.06%, 0.08%, or 0.1%.

In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of the 0.04% and 0.1% clinical formulations. A dose-dependent incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1 mg/kg/day tretinoin, respectively. These doses are two and four times the MRHD based on BSA comparison.

The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the MRHD based on BSA comparison). Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources [see Warnings and Precautions (5.3)].

The genotoxic potential of tretinoin was evaluated in the Ames assay and an in vivo mouse micronucleus assay. Both tests were negative.

The components of the microspheres have shown potential for genetic toxicity and fetal malformation. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in an in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, and an in vivo mouse micronucleus assay.

In fertility studies in rats with oral tretinoin, the no-observable effect level was 2 mg/kg/day (19 times the MRHD based on BSA comparison).

Clinical Pharmacology for Retin-A Micro

Mechanism of Action

Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors and/or other mechanisms.

The exact mechanism of action of topical tretinoin for treatment of acne vulgaris is unknown. Current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Pharmacodynamics

The pharmacodynamics of RETIN-A MICRO is unknown.

Pharmacokinetics

Absorption

Tretinoin is a metabolite of Vitamin A. Percutaneous absorption, as determined by the cumulative excretion of radiolabeled drug into urine and feces, was assessed in 44 healthy males and females after single and repeated daily tretinoin applications up to 28 days of 500 mg of a 0.1% tretinoin gel product. In this assessment, estimates of in vivo bioavailability, mean (SD) were 0.82 (0.11)% and 1.41 (0.54)%, for single and multiple daily topical applications, respectively. The plasma concentrations of tretinoin and its metabolites, 13-cisretinoic acid, all-trans-4-oxo-retinoic acid, and 13-cis-4-oxo-retinoic acid, generally ranged from 1 to 3 ng/mL and were essentially unaltered after either single or multiple daily applications of RETIN-A MICRO, 0.1%, relative to baseline levels. 

Clinical pharmacokinetic studies have not been performed with RETIN-A MICRO, 0.08%, 0.06% and 0.04%.

Clinical Studies

Clinical Studies of RETIN-A MICRO, 0.1%

The efficacy of RETIN-A MICRO, 0.1 was evaluated in two double-blind, randomized, vehicle-controlled trials in adult and pediatric subjects 11 years of age and older with acne vulgaris (Studies 1 and 2). RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age. RETIN-A MICRO, 0.1%, applied topically once daily in the evening, was superior to vehicle gel, applied topically once daily, in reducing the acne lesion counts. The mean reduction in lesion counts from baseline after treatment for 12 weeks are shown in Table 1:

Table 1: Mean Percent Reduction in Lesion Counts in Subjects with Acne Vulgaris at Week 12 in Studies 1 and 2

	Retin-A Micro (tretinoin gel) microsphere, 0.1%		Vehicle Gel
	Study #1 72 pts	Study #2 71 pts	Study #1 72 pts	Study #2 67 pts
Non-inflammatory lesion counts	49%	32%	22%	3%
Inflammatory lesion counts	37%	29%	18%	24%
Total lesion counts	45%	32%	23%	16%

Efficacy was also assessed by the investigator’s global evaluation, which included categories of “excellent”, “good”, “fair”, “no change”, and “poor”. RETIN-A MICRO 0.1%, was significantly superior (p<0.001) to the vehicle in the investigator's global evaluation of the clinical response:

• In Study 1, 35% of RETIN-A MICRO 0.1% -treated subjects achieved an “excellent” result, as compared to 11% of vehicle-treated subjects.
• In Study 2, 28% of RETIN-A MICRO 0.1%-treated subjects achieved an “excellent” result, as compared to 9% of vehicle-treated subjects.

Clinical Studies with RETIN-A MICRO, 0.04%

In two vehicle-controlled clinical trials in adult and pediatric subjects 11 years of age and older with acne vulgaris (Studies 3 and 4). RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age. RETIN-A MICRO, 0.04%, applied topically once daily in the evening, was more effective (p<0.05) than vehicle gel, applied topically once daily, in reducing the acne lesion counts. The mean reduction in lesion counts from baseline after treatment for 12 weeks are shown in Table 2:

Table 2: Mean Percent Reduction in Lesion Counts in Subjects with Acne Vulgaris at Week 12 in Studies 3 and 4

	Retin-A Micro (tretinoin gel) microsphere, 0.04%		Vehicle Gel
	Study #1 108 pts	Study #2 111 pts	Study #1 110 pts	Study #2 103 pts
Non-inflammatory lesion counts	37%	29%	-2%*	14%
Inflammatory lesion counts	44%	41%	13%	30%
Total lesion counts	40%	35%	8%	20%
* - That is, a mean percent increase of 2%

Efficacy was also assessed by the investigator's global evaluation, which included categories of “excellent”, “good”, “fair”, “no change”, and “poor”. RETIN-A MICRO 0.04% was superior (p<0.05) to the vehicle in the investigator's global evaluation of the clinical response:

• In Study 3, 14% of RETIN-A MICRO 0.04%-treated subjects achieved an “excellent” result, as compared to 5% of vehicle-treated subjects.
• In Study 4, 19% of RETIN-A MICRO 0.04%-treated subjects achieved an “excellent” result, as compared to 9% of vehicle-treated subjects.

Patient Information for Retin-A Micro

RETIN-A MICRO® (ret-in-A MY-kroe) (tretinoin) gel for topical use

Important information: RETIN-A MICRO is for use on skin (topical use) only. Keep RETIN-A-MICRO away from your eyes, mouth, vagina, or the corners of your nose.

What is RETIN-A MICRO?

RETIN-A MICRO is a prescription medicine used on the skin (topical) to treat acne in adults and children 12 years of age and older. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if RETIN-A MICRO is safe and effective in children under 12 years of age.

Before using RETIN-A MICRO, tell your healthcare provider about all of your medical conditions, including if you:

• have a skin condition called eczema.
• have a sunburn. You should not use RETIN-A MICRO until your skin has healed.
• are pregnant or plan to become pregnant. It is not known if RETIN-A MICRO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if RETIN-A MICRO passes into your breast milk. If you breastfeed during treatment with RETIN-A MICRO, use RETIN-A MICRO on the smallest area of the skin with acne and for the shortest time possible. Do not apply RETIN-A MICRO directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use any skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Using these topical skin products may increase the irritation of your skin when used with RETIN-A MICRO.

How should I use RETIN-A MICRO?

• Use RETIN-A MICRO exactly as your healthcare provider tells you to use it.
• Before you apply RETIN-A MICRO, gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry.
• Apply a thin layer of RETIN-A MICRO to the affected area 1 time a day in the evening.
• Do not use more RETIN-A MICRO than you need to cover the affected area and do not apply RETIN-A MICRO more than 1 time a day. Using too much RETIN-A MICRO or using it too often will not give you faster or better results, and you may get skin redness, peeling, or discomfort.
• You may use moisturizers after applying RETIN-A MICRO.
• Early in your treatment, you may get new pimples. At this stage, it is important to continue using RETIN-A MICRO.
• Your acne may not get better right away. Improvement in your acne may be noticed after 2 weeks of RETIN-A MICRO treatment, but more than 7 weeks of treatment may be needed before you get the full benefit.
• Wash your hands after applying RETIN-A MICRO.
• RETIN-A MICRO taken by mouth in large amounts may lead to the same side effects as those seen with large amounts of Vitamin A taken by mouth. Call the Poison Help line at 1-800-222-1222 if RETIN-A MICRO is taken by mouth.

What should I avoid while using RETIN-A MICRO?

• You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with RETIN-A MICRO. Minimize exposure to sunlight.
• If you have to be in the sunlight, are sensitive to sunlight, or are using medicine that cause sensitive to sunlight, use a sunscreen with sun protection factor (SPF) of 15 or more. Wear a wide-brimmed hat or other protective clothing to cover the treated areas, even on days when it is not sunny, or you are inside.
• Do not use RETIN-A MICRO on sunburn skin until your skin has healed.

What are the possible side effects of RETIN-A MICRO?

RETIN-A MICRO can cause serious side effects, including:

• Skin irritation. RETIN-A MICRO can cause skin dryness, redness, swelling, peeling, itching, blistering, burning, or stinging. If you develop these symptoms, your healthcare provider may temporarily stop or completely stop your treatment with RETIN-A MICRO.

To help reduce the risk of skin irritation with RETIN-A MICRO:

• Avoid use of RETIN-A MICRO in skin areas affected by eczema.
• Minimize or avoid use of RETIN-A MICRO with weather extremes, such as severe wind or cold.
• Avoid washing the treated skin too often or scrubbing it hard when washing.
• RETIN-A MICRO is not recommended with use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high amounts of alcohol, astringents, spices, or lime peels.
• Apply a topical moisturizer when using RETIN-A MICRO.
• It is not known if RETIN-A MICRO is effective when used less than 1 time a day.
• Sensitivity to sunlight. See "What should I avoid while using RETIN-A MICRO?"

The most common side effects of RETIN-A MICRO include skin redness, pain, and itching. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of RETIN-A MICRO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store RETIN-A MICRO?

• Store RETIN-A MICRO at room temperature between 68° to 77°F (20° to 25°C).
• Store RETIN-A MICRO pump upright.
• Keep RETIN-A MICRO and all medicines out of the reach of children.

General information about the safe and effective use of RETIN-A MICRO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use RETIN-A MICRO for a condition for which it was not prescribed. Do not give RETIN-A MICRO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RETIN-A MICRO that is written for health professionals.

What are the ingredients of RETIN-A MICRO?

Active ingredient: tretinoin

Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, methyl methacrylate/glycol dimethacrylate crosspolymer, PPG-20 methyl glucose ether distearate, propylene glycol, propylene glycol dicaprylate/dicaprate, purified water, sorbic acid, and trolamine

---

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada