PROACTIV MD ADAPALENE  ACNE TREATMENT- adapalene gel 
The Proactiv Company, LLC

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Proactiv MD® Adapalene Gel 0.1%
Acne Treatment

Drug Facts

Active ingredient

Adapalene 0.1% (retinoid)1


1
read consumer information leaflet

Purpose

Acne treatment

Use

Warnings

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.

If pregnant or breast-feeding, ask a doctor before use.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

Children under 12 years of age: ask a doctor

Other information

Inactive ingredients

carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.

Questions?

1-866-735-4137

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

proactiv MD®

ADAPALENE GEL 0.1%
ACNE TREATMENT

First FDA-Approved
Over-the-Counter
Topical Retinoid* for
Acne Treatment

Previously Available
Only By Prescription

Dermatologist
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)

PRINCIPAL DISPLAY PANEL - 15 g Tube Box
PROACTIV MD ADAPALENE   ACNE TREATMENT
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-956
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Adapalene (UNII: 1L4806J2QF) (Adapalene - UNII:1L4806J2QF) Adapalene0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-956-441 in 1 BOX03/27/2017
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-956-171 in 1 BOX03/27/2017
245 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11410-956-381 in 1 BLISTER PACK08/09/2017
32 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02038003/27/2017
Labeler - The Proactiv Company, LLC (080216357)

Revised: 8/2017
Document Id: 0c886303-dcf9-48f5-970c-83fd62d1a0aa
Set id: ab771c7e-ed01-442c-be0e-d368db6e4100
Version: 3
Effective Time: 20170810
 
The Proactiv Company, LLC