April 26, 2017
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"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.




How Supplied


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.


RETIN-A Gel, Cream or Liquid should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Liquid: The liquid may be applied using a fingertip, gauze pad, or cotton swab. If gauze or cotton is employed, care should be taken not to oversaturate it to the extent that the liquid would run into areas where treatment is not intended. Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application 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 two to three weeks but more than six 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.)


RETIN-A (tretinoin) is supplied as:

RETIN-A Cream RETIN-A Strength/ Form RETIN-A Gel RETIN-A Liquid
NDC Code RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty.
0062-0165-01 0.025% Cream 20g 0062-0575-44 0.01% Gel 15g 0062-0075-07 0.05% Liquid 28mL
0062-0165-02 0.025% Cream 45g 0062-0575-46 0.01% Gel 45g      
0062-0175-12 0.05% 20g 0062-0475-42 0.025% Gel 15g      
0062-0175-13 0.05% Cream 45g 0062-0475-45 0.025% Gel 45g      
0062-0275-23 0.1% Cream 20g            
0062-0275-01 0.1% Cream 45g            

Storage Conditions

RETIN-A Liquid, 0.05%, and 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.

Marketed by: Ortho Dermatologics™. Manufactured by: DRAXIS Specialty Pharmaceuticals, Inc., Qc, Canada H9H 4J4

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/4/2017

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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