Adapalene Solution

Name: Adapalene Solution

Contraindications

Adapalene Topical Solution 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

Warnings

Use of Adapalene Topical Solution 0.1% should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

Adverse reactions

Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with the use of similar products during clinical trials were reversible upon discontinuation of therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Rochester Pharmaceuticals at 1-866-458-1772 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Adapalene Topical Solution 0.1% is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. The acute oral toxicity of Adapalene Topical Solution 0.1% in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

How supplied

Adapalene Topical Solution 0.1% is supplied in the following size:

60 mL glass bottle – NDC 49908-117-60

Storage: Store at 20° to 25°C (68° to 77°F).  [See USP controlled room temperature]

CAUTION: Federal law prohibits dispensing without prescription.

Distributed by:Rochester Pharmaceuticals

Doylestown, PA 18901

Rev. #, Date: 09/15

NDC 49908-117-60

Rx Only

Adapalene Topical Solution, 0.1%

For External Use Only

Not for Ophthalmic Use

60 mL

Rochester Pharmaceuticals

ADAPALENE TOPICAL SOLUTION 
adapalene topical solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-117
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (ADAPALENE) ADAPALENE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400  
ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:49908-117-60 1 BOTTLE, GLASS in 1 CARTON
1 60 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203981 10/03/2016
Labeler - CALL INC (d.b.a Rochester Pharmaceuticals) (134473771)
Revised: 09/2016   CALL INC (d.b.a Rochester Pharmaceuticals)
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