Adapalene Gel USP, 0.3%

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel,0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Each gram of adapalene gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

11 DESCRIPTION

DESCRIPTION SECTION

Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

The safety and efficacy of once daily use of adapalene gel, 0.3% for treatment of acne vulgaris were assessed in one 12 week, multi­ center, controlled, clinical trial, conducted in a total of 653 subjects 12 to 52 years of age with acne vulgaris of mild to moderate severity. All female subjects of child-bearing potential enrolled in the trial were required to have a negative urine pregnancy test at the beginning of the trial and were required to practice a highly effective method of contraception during the trial. Female subjects who were pregnant, nursing or planning to become pregnant were excluded from the trial. Subjects enrolled in the trial were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%). An equal number of males (49.5%) and females (50.5%) enrolled. Success was defined as "Clear'" or "Almost Clear" in the Investigator's Global Assessment (IGA). The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table: Table 3: Clinical study primary efficacy results at Week 12 Adapalene Gel, 0.3% Adapalene Gel, 0.1% Vehicle Gel N = 258 N = 261 N = 134 IGA Success Rate 53 (21%) 41 (16%) 12 (9%) Inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 27.7 14.4 (51.6%) 28.1 13.9 (49.7%) 27.2 11.2 (40.7%) Non-inflammatory Lesions Mean Baseline Count Mean Absolute(%) Reduction 39.4 16.3 (39.7%) 41.0 15.2 (35.2%) 40.0 10.3 (27.2%) Total Lesions Mean Baseline Count Mean Absolute(%) Reduction 67.1 30.6 (45.3) 69.1 29.0 (41.8%) 67.2 21.4 (33.7%)

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Adapalene Gel, USP,0.3% is supplied in the following size. 45g tube- NDC 21922-051-06 45g pump- NDC 21922-051-50 Storage : Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene gel, 0.3% should receive the following information and instructions. 1. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non- medicated soap. 2. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes 3. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. 4. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. 5. Wax depilation should not be performed on treated skin due to the potential for skin erosions 6. Minimize exposure to sunlight including sunlamps Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. 7. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. 8. This product is for external use only. 9. Lactation: Use Adapalene gel. 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [See Use in Specific Populations, Lactation ( 8.2 ) ] Made in Spain, formulated in India.

Patient Information

SPL PATIENT PACKAGE INSERT SECTION

Adapalene Gel, [a-DAP-a-leen] Important: Adapalene Gel, 0.3% is for use on the skin only (topical). Do not use adapalene gel, 0.3%in or on your mouth, eyes, or vagina. What is Adapalene gel, 0.3%? Adapalene Gel, 0.3% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. It is not known if adapalene gel, 0.3% is safe and effective in children under 12 years of age or in people 65 years of age and older. Do not use Adapalene Gel, 0.3% if you are allergic to adapalene or any of the ingredients in adapalene gel, 0.3%. See the end of this Patient Information leaflet for a complete list of ingredients in adapalene gel, 0.3%. Before using adapalene gel, 0.3%, tell your healthcare provider about all your medical conditions, including if you: have other skin problems, including cuts, abrasions, sunburn, or skin that is dry, itchy, or red. are pregnant or plan to become pregnant. It is not known if Adapalene Gel, 0.3%, can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Adapalene Gel, 0.3% passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use adapalene gel, 0.3%. If you use adapalene gel, 0.3% while breastfeeding, use adapalene gel, 0.3% on the smallest area of the skin and for the shortest time needed. Do not apply adapalene gel, 0.3% to areas that may increase the risk of getting adapalene gel, 0.3% in your child's mouth or eyes. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Adapalene gel, 0.3%? • Use adapalene gel, 0.3% exactly as your healthcare provider tells you to use it. • Apply adapalene gel,0.3% 1 time a day in the evening. • Tell your healthcare provider if you do not notice a difference in your acne after using DIFFERIN Gel for 12 weeks. Applying adapalene gel, 0.3%: • Wash the area where adapalene gel, 0.3% will be applied with a mild soap that does not contain a medicine and pat dry. • Adapalene Gel, 0.3% comes in a tube and a pump. If you have been prescribed the: o Tube: Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas. o Pump: Depress the pump to dispense a small amount of adapalene gel, 0.3% and spread a thin layer over the entire face and any other affected area. o Do not apply adapalene gel, 0.3% on areas of the skin around your eyes, lips, nose, and mouth. • Wash your hands after applying adapalene gel,0.3% What should I avoid while using Adapalene Gel, 0.3%? • Avoid spending time in sunlight, including sunlamps. adapalene gel,0.3% can make your skin sensitive to the sun and the light from sunlamps. Use sunscreen and wear hat and clothes that cover the areas treated with adapalene gel, 0.3% if you have to be in sunlight. • Cold weather and wind may irritate your skin treated with adapalene gel, 0.3%. • Do not apply adapalene gel, 0.3 % to cuts, abrasions, sunburned skin, or skin that is dry, itchy, or red. • Avoid skin products that may dry or irritate your skin such as harsh soaps or cleansers, soaps and cosmetics that make your skin dry, and products that contain high levels of alcohol, astringents, spices, or limes. • Avoid the use of "waxing" as a hair removal method on skin treated with adapalene gel. What are the possible side effects of adapalene gel, 0.3%?Adapalene Gel, 0.3% may cause serious side effects including: • Allergic reactions. Adapalene Gel, 03% may cause serious allergic reactions that sometimes may require medical treatment. Stop using adapalene gel, 0.3% and tell your healthcare provider or get medical help right away if you have any of these symptoms of an allergic reaction: • skin rash, itching or hives • trouble breathing or chest pain • swelling of your face, eyes, lips, tongue, or throat • Skin reactions at the treated site. Adapalene Gel, 0.3% may cause skin reactions including redness, scaling, dryness, stinging, and burning. These skin reactions are most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of adapalene gel, 0.3%. Your healthcare provider may tell you to use a moisturizer, decrease how often you use adapalene gel, 0.3%, or stop treatment with adapalene gel, 0.3% if you get any skin reactions. If you use a moisturizer, you should avoid moisturizers that contain alpha hydroxy or glycolic acid. Ask your healthcare provider or pharmacist if you are not sure. The most common side effects of adapalene gel, 0.3% include dry skin, skin pain, itching, and skin peeling. These are not all the possible side effects of adapalene gel, 0.3%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Encube Ethicals Private Limited at 1-833-285-4151. How should I store adapalene gel, 0.3%? • Store adapalene gel, 0.3% at room temperature between 68° F to 77° F (20°C to 25°C). • Do not freeze Adapalene Gel, 0.3%. Keep Adapalene Gel, 0.3% and all medicines out of the reach of children. General information about the safe and effective use of Adapalene gel,0.3% Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use adapalene gel, 0.3% for a condition for which it was not prescribed. Do not give adapalene gel, 0.3% to other people, even if they have the same symptoms you have. It may harm them. You can also ask your pharmacist or healthcare provider for information about adapalene gel, 03% that is written for health professionals. What are the ingredients in Adapalene gel,0.3%? Active ingredient: adapalene Inactive ingredients: carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid for pH adjustment. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim,Post: Mardol, Panda, Goa-403404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. 02/2024

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label NDC 21922- 051 -50 Adapalene Gel, USP 0.3% PUMP FOR TOPICAL USE ONLY Net Wt. 45g Rx only Carton Label NDC 21922- 051 -06 Adapalene Gel, 0.3% For topical use only. Not for ophthalmic, oral or intravaginal use. Net Wt. 45g Rx only