Label: PROACTIV MD ADAPALENE ACNE TREATMENT- adapalene gel
- NDC Code(s): 11410-956-17, 11410-956-38, 11410-956-44
- Packager: The Proactiv Company, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Updated August 10, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Do not use
- on damaged skin (cuts, abrasions, eczema, sunburn)
- if you are allergic to adapalene or any of the ingredients in this product.
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
Stop use and ask a doctor if
- you become pregnant, or are planning to become pregnant, while using the product
- you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
- irritation becomes severe
- you see no improvement after 3 months of once daily use
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
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 15 g Tube Box
ADAPALENE GEL 0.1%
Topical Retinoid* for
Only By Prescription
Developed and Tested
*Read carton and enclosed consumer
information leaflet before using
this product. Keep this carton and
consumer information leaflet.
They contain important information.
NET WT 0.5 OZ (15 g)
INGREDIENTS AND APPEARANCE
PROACTIV MD ADAPALENE ACNE TREATMENT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-956 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Adapalene (UNII: 1L4806J2QF) (Adapalene - UNII:1L4806J2QF) Adapalene 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 182 (UNII: JX0HIX6OAG) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-956-44 1 in 1 BOX 03/27/2017 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11410-956-17 1 in 1 BOX 03/27/2017 2 45 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11410-956-38 1 in 1 BLISTER PACK 08/09/2017 3 2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA020380 03/27/2017 Labeler - The Proactiv Company, LLC (080216357)