Adapalene Lotion

Apply a thin layer of Adapalene Lotion to the entire face and other affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of Adapalene Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes.

Adapalene Lotion is for topical use only and not for oral, ophthalmic, or intravaginal use.

Concomitant Topical Medications

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Caution should be exercised in using preparation containing sulfur, resorcinol or salicylic acid in combination with Adapalene Lotion.

No formal drug-drug interaction studies were conducted with Adapalene Lotion.

Adapalene Lotion, 0.1% for topical use, contains adapalene in a white to off-white oil-in-water emulsion. Adapalene is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid).
Adapalene has the following structural formula:

Adapalene:
Molecular formula: C28H28O3 Molecular weight: 412.5

Each gram of Adapalene Lotion contains 1 mg of adapalene. The lotion also contains the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol.

The safety and efficacy of Adapalene Lotion applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical trials of similar design, comparing Adapalene Lotion to the lotion vehicle in acne subjects.
In Trial 1, 1075 subjects were randomized to Adapalene Lotion or vehicle. The median age of these subjects was 16.7 years old and 53.1% were females. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects (91.0%) had a baseline IGA score of ‘Moderate’. In Trial 2, 1066 subjects were randomized to Adapalene Lotion or vehicle.
The median age of subjects was 16.7 years old and 53.7% were females. At baseline subjects had the same inclusion criteria as in Trial 1 and 95.7% of subjects had a baseline IGA score of ‘Moderate’. The outcome of the two trials is presented in Table 3.

Adapalene Lotion, 0.1%, is a white to off-white liquid packaged in a 2 oz (59 mL) bottle which is equipped with a lotion dispensing pump.
Adapalene Lotion is supplied as follows:

2 oz bottle pump NDC 69007-912-02

Storage and handling

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [see USP Controlled Room temperature]
• Do not freeze.
• Do not refrigerate.
• Protect from light.
• Keep out of reach of children.
• Keep away from heat.
• Keep bottle tightly closed.

NDC 69007-912-02

Rx only

Adapalene Lotion, 0.1%

OWEN

For External Use Only

2 FL OZ

(59 mL)

For external use only. Not for ophthalmic, oral or intravaginal use.

Usual dosage: Apply a thin layer on the entire face and other affected areas of the skin once daily. See package insert for complete prescribing information.

Each gram contains: adapalene 1 mg (0.1%) in an aqueous based lotion consisting of the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, purified water, sodium hydroxide, and stearyl alcohol.

Storage: Store at controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F and 86°F (15°C and 30°C). Do not freeze or refrigerate.

Distributed by:

Owen Laboratories, Inc.,

a Galderma Company

Fort Worth, Texas 76177 USA

Galderma is a registered trademark.

Made in Canada

P52441-0