Tretinoin

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Tretinoin gel (microsphere) is a retinoid indicated for topical application in the treatment of acne vulgaris.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For topical use only. Not for ophthalmic, oral, or intravaginal use. Tretinoin gel (microsphere) should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area in a thin layer. Areas to be treated should be cleansed thoroughly before the medication is applied. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy [see Adverse Reactions (6.1) ]. Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed. Tretinoin gel (microsphere) should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. Patients treated with tretinoin gel microsphere may use cosmetics. Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with tretinoin gel (microsphere). It also is advisable to allow the effects of such preparations to subside before use of tretinoin gel (microsphere) is begun.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Tretinoin gel (microsphere) is a white to very pale yellow opaque gel. Tretinoin gel (microsphere) is available in strength: 0.08%. Each gram of tretinoin gel (microsphere), 0.08%, contains 0.8 mg of tretinoin.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None.

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

Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

11 DESCRIPTION

DESCRIPTION SECTION

Tretinoin gel (microsphere), 0.08% is a white to very pale yellow opaque gel for topical treatment of acne vulgaris. Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1- cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds 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: Each gram of tretinoin gel (microsphere), 0.08%, contains 0.8 mg of tretinoin. The formulation uses acrylate copolymer microsphere system to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. 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, propylene glycol dicaprylate/dicaprate, purified water, sorbic acid, and trolamine.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Tretinoin gel (microsphere) is opaque and white to very pale yellow in color. Tretinoin gel (microsphere), 0.08%, is supplied in 50 gram pump. NDC 72162-2303-2 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. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information). The patient should be instructed to: Cleanse the treatment area thoroughly, before treatment, with a mild, non-medicated cleanser. Do not use more than the recommended amount and do not apply tretinoin gel (microsphere) more than once daily as this will not produce faster or better results, but may increase irritation. Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Manufactured by: Encube Ethicals Private Limited. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc . 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Patient Information Tretinoin Gel (Microsphere) (truh•ti•now•uhn) Tretinoin Gel (microsphere) 0.08%, for topical use Important information: Tretinoin gel (microsphere) is for use on skin only. Do not get tretinoin gel (microsphere) in your eyes, mouth, vagina or the corners of your nose. What is Tretinoin gel (microsphere)? Tretinoin gel (microsphere) is a prescription medicine used on the skin (topical) to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if tretinoin gel (microsphere) is safe and effective in the treatment of other conditions. It is not known if tretinoin gel (microsphere) is safe and effective in children under 12 years of age. What should I tell my doctor before using tretinoin gel (microsphere)? Before using tretinoin gel (microsphere), tell your doctor about all of your medical conditions, including if you: have a skin condition called eczema. have a sunburn. You should not use tretinoin gel (microsphere) until your skin has healed. have any other medical condition. are pregnant or plan to become pregnant. It is not known if tretinoin gel (microsphere) will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if tretinoin gel (microsphere) passes into your breast milk. Tell your doctor about all of the medicines you take, including prescription and over-the counter medicines, vitamins, herbal supplements, and any skin products that you use. Especially tell your doctor if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with tretinoin gel (microsphere). Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use tretinoin gel (microsphere)? Use tretinoin gel (microsphere) exactly as your doctor tells you to use it. Your doctor may change your dose of tretinoin gel (microsphere) if you have skin irritation. Before you apply tretinoin gel (microsphere), gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry. Apply tretinoin gel (microsphere) 1 time a day in the evening, or as prescribed by your doctor. Do not use more tretinoin gel (microsphere) than you need to cover the affected area and do not apply tretinoin gel (microsphere) more than 1 time a day. Using too much tretinoin gel (microsphere) or using it too often will not give you faster or better results, and you may get skin redness, peeling, or discomfort. You may have a brief feeling of warmth or slight stinging after applying tretinoin gel (microsphere). You may use moisturizers and cosmetics. Early in your treatment, you may get new pimples. At this stage, it is important to continue using tretinoin gel (microsphere). Your acne may not get better right away. Use tretinoin gel (microsphere) even after your acne improves. Your acne may get better after two weeks of treatment, but more than seven weeks of tretinoin gel (microsphere) treatment are needed before you get the full benefit. Applying tretinoin gel (microsphere): Tretinoin gel (microsphere) comes in a pump. If you have been prescribed the: Pump: Fully depress the pump twice to dispense tretinoin gel (microsphere) onto a fingertip. Apply a thin layer to cover the affected area, as prescribed by your doctor. Spread tretinoin gel (microsphere) evenly over the affected area. Wash your hands after applying tretinoin gel (microsphere). What should I avoid while using tretinoin gel (microsphere)? Avoid washing your skin too often and scrubbing the affected skin area. You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with tretinoin gel (microsphere). Minimize exposure to sunlight. If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with SPF (sun protection factor) of 15 or more and wear a wide-brimmed hat or other protective clothing to cover the treated areas. If you do get sunburned, stop using tretinoin gel (microsphere) until your skin has healed and is back to normal. Cold weather and wind may irritate skin treated with tretinoin gel (microsphere). Talk to your doctor about ways to manage skin irritation. Avoid contact with the peels of limes. What are the possible side effects of tretinoin gel (microsphere)? Tretinoin gel (microsphere) may cause serious side effects, including: Skin irritation . Tretinoin gel (microsphere) may cause skin dryness, redness, swelling, and blistering. If you develop these symptoms, your doctor may tell you to stop using tretinoin gel (microsphere) for a while, change your dose, decrease the number of times you apply tretinoin gel (microsphere), or completely stop treatment with tretinoin gel (microsphere). It is not known if tretinoin gel (microsphere) is effective when used less than 1 time a day. The most common side effects of tretinoin gel (microsphere) include skin burning and itching. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of tretinoin gel (microsphere). For more information, ask your doctor or pharmacist. 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 tretinoin gel (microsphere)? Store tretinoin gel (microsphere) at room temperature between 68°F to 77°F (20°C to 25°C). Store tretinoin gel (microsphere) pump upright. Keep tretinoin gel (microsphere) and all medicines out of the reach of children. General information about the safe and effective use of tretinoin gel (microsphere). Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tretinoin gel (microsphere) for a condition for which it was not prescribed. Do not give tretinoin gel (microsphere) to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about tretinoin gel (microsphere) that is written for health professionals. For more information, call 1-833-285-4151. What are the ingredients of tretinoin gel (microsphere)? Active ingredient: tretinoin Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, propylene glycol dicaprylate/dicaprate, purified water, sorbic acid and trolamine. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Encube Ethicals Private Limited Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc . 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Revised- 08/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tretinoin 0.08% Gel (Microsphere), PUMP