Adapalene Gel 0.1% - Drug Facts
Drug Facts
Proactiv Md Kit
FDA Label NDC 11410-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alchemee, Llc for the product Proactiv Md Kit (NDC 11410-224). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding adapalene gel 0.1% - drug facts, adapalene gel 0.1% - active ingredient, adapalene gel 0.1% - purpose, adapalene gel 0.1% - use, adapalene gel 0.1% - warnings, otc - do not use, adapalene gel 0.1% - when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Adapalene Gel 0.1% - Active Ingredient
Adapalene Gel 0.1% (retinoid)
Adapalene Gel 0.1% - Purpose
Acne treatment
Adapalene Gel 0.1% - Use
for the treatment of acne
Adapalene Gel 0.1% - Warnings
For external use only
Otc - Do Not Use
Do not use
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you're allergic to adapalene or any of the ingredients in this product
Adapalene Gel 0.1% - When Using This Product
- limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
- do not wax to remove hair in areas where the product has been applied
- during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
- irritation (redness, itching, dryness, burning) is more likely to occur:
- in the first few weeks of use
- if using more than one topical acne medication at a time
- but irritation usually lessens with continued use of this product
- it may take up to 3 months of once daily use to see results
- avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
- wash hands after use
- irritation (redness, itching, dryness, burning) is more likely to occur:
Stop Use And Ask A Doctor If
- irritation becomes severe.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Adapalene Gel 0.1% - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Adapalene Gel 0.1% - Directions
Adults and children 12 years of age and older:
- use once daily
- clean the skin gently and pat dry before applying the product
- cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
- do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.
Children under 12 years of age: ask a doctor
Adapalene Gel 0.1% - Other Information
- Store at room temperature 68o – 77oF
- protect from freezing
Adapalene Gel 0.1% - Inactive Ingredients
carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydroxide, water
Questions Or Comments?
1-800-950-4695
Other
Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign
and Domestic Components
Questions? 1-800-950-4695 • proactiv.com
Proactiv is a registered trademark
of Taro Pharmaceuticals U.S.A., Inc.
Principal Display Panel - Proactivmd Kit
proactiv®
ProactivMD
3-step acne treatment system
Featuring our prescription-strength retinoid
Step 1: Cleanse
Washes away debris & oil
Step 2: Treat
First FDA-approved over-the-counter topical retinoid* for acne treatment
Previously available only by prescription.
Dermatologist developed and tested
*Read carton an consumer leaflet information before using
Step 3: Hydrate
Keeps skin hydrated & refreshed
Kit Contains: Ultra-Gentle Cleaner 2 FL. OZ. (60 mL) Adapalene Gel 0.1% 0.5 FL. OZ. (15 g) Ultra-Hydrating Moisturizer 1 FL. OZ. (30 mL)
* Please review the disclaimer below.
