Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED RETIN-A (tretinoin) is supplied as: RETIN-A Cream RETIN-A Gel NDC Code RETIN-A Strength/ Form RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty. 0187-5160-20 0.025% Cream 20 g 0187-5172-15 0.01% Gel 15 g 0187-5160-45 0.025% Cream 45 g 0187-5172-45 0.01% Gel 45 g 0187-5162-20 0.05% Cream 20 g 0187-5170-15 0.025% Gel 15 g 0187-5162-45 0.05% Cream 45 g 0187-5170-45 0.025% Gel 45 g 0187-5164-20 0.1% Cream 20 g 0187-5164-45 0.1% Cream 45 g Storage Conditions: RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.; PRINCIPAL DISPLAY PANEL - 0.025% 45 g Cream Carton NDC 0187-5160-45 Retin-A ® Cream (tretinoin) 0.025% Each gram contains: Tretinoin 0.025%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton1; PRINCIPAL DISPLAY PANEL - 0.05% 45 g Cream Carton NDC 0187-5162-45 Retin-A ® Cream (tretinoin) 0.05% Each gram contains: Tretinoin 0.05%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton2; PRINCIPAL DISPLAY PANEL - 0.1% 45 g Cream Carton NDC 0187-5164-45 Retin-A ® Cream (tretinoin) 0.1% Each gram contains: Tretinoin 0.1%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton3; PRINCIPAL DISPLAY PANEL - 0.01% 45 g Gel Carton NDC 0187-5172-45 Retin-A ® Gel (tretinoin) 0.01% Each gram contains: Tretinoin 0.01%, butylated hydroxytoluene, hydroxypropyl cellulose and alcohol, (denatured with tert- butyl alcohol and brucine sulfate) 90% w/w. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 86°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton4; PRINCIPAL DISPLAY PANEL - 0.025% 45 g Gel Carton NDC 0187-5170-45 Retin-A ® Gel (tretinoin) 0.025% Each gram contains : Tretinoin 0.025%, butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert- butyl alcohol and brucine sulfate) 90% w/w. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 86°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton5
- HOW SUPPLIED RETIN-A (tretinoin) is supplied as: RETIN-A Cream RETIN-A Gel NDC Code RETIN-A Strength/ Form RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty. 0187-5160-20 0.025% Cream 20 g 0187-5172-15 0.01% Gel 15 g 0187-5160-45 0.025% Cream 45 g 0187-5172-45 0.01% Gel 45 g 0187-5162-20 0.05% Cream 20 g 0187-5170-15 0.025% Gel 15 g 0187-5162-45 0.05% Cream 45 g 0187-5170-45 0.025% Gel 45 g 0187-5164-20 0.1% Cream 20 g 0187-5164-45 0.1% Cream 45 g Storage Conditions: RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.
- PRINCIPAL DISPLAY PANEL - 0.025% 45 g Cream Carton NDC 0187-5160-45 Retin-A ® Cream (tretinoin) 0.025% Each gram contains: Tretinoin 0.025%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton1
- PRINCIPAL DISPLAY PANEL - 0.05% 45 g Cream Carton NDC 0187-5162-45 Retin-A ® Cream (tretinoin) 0.05% Each gram contains: Tretinoin 0.05%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton2
- PRINCIPAL DISPLAY PANEL - 0.1% 45 g Cream Carton NDC 0187-5164-45 Retin-A ® Cream (tretinoin) 0.1% Each gram contains: Tretinoin 0.1%, stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 80°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton3
- PRINCIPAL DISPLAY PANEL - 0.01% 45 g Gel Carton NDC 0187-5172-45 Retin-A ® Gel (tretinoin) 0.01% Each gram contains: Tretinoin 0.01%, butylated hydroxytoluene, hydroxypropyl cellulose and alcohol, (denatured with tert- butyl alcohol and brucine sulfate) 90% w/w. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 86°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton4
- PRINCIPAL DISPLAY PANEL - 0.025% 45 g Gel Carton NDC 0187-5170-45 Retin-A ® Gel (tretinoin) 0.025% Each gram contains : Tretinoin 0.025%, butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert- butyl alcohol and brucine sulfate) 90% w/w. For Topical Use Only Rx only Usual Dosage: See package insert. Store below 86°F. WARNING: Keep out of reach of children. Net Wt. 45 g carton5
Overview
RETIN-A Gel and Cream, containing tretinoin, are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert -butyl alcohol and brucine sulfate) 90% w/w. RETIN-A (tretinoin) Cream contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all - trans -retinoic acid and has the following structure: Chemical Structure
Indications & Usage
RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Dosage & Administration
RETIN-A Gel or Cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of overapplication by the patient. Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after 2 to 3 weeks but more than 6 weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms. Patients treated with RETIN-A (tretinoin) acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied (see PRECAUTIONS ).
Warnings & Precautions
No warnings available yet.
Contraindications
Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
Adverse Reactions
The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of RETIN-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with RETIN-A. To date, all adverse effects of RETIN-A have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with RETIN-A. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of RETIN-A is begun.
Storage & Handling
Storage Conditions: RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.
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