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Proactiv MD Adapalene Acne Treatment

Dosage form: gel
Ingredients: Adapalene 0.1g in 100g
Labeler: The Proactiv Company, LLC
NDC Code: 11410-956

Proactiv MD® Adapalene Gel 0.1%
Acne Treatment

Drug Facts

Active ingredient

Adapalene 0.1% (retinoid)


read consumer information leaflet

Purpose

Acne treatment

Use
  • For the treatment of acne

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:

  • 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
  • store at room temperature 68°- 77°F
  • protect from freezing

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)

PROACTIV MD ADAPALENE   ACNE TREATMENT
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-956
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Adapalene (Adapalene) Adapalene0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
METHYLPARABEN 
POLOXAMER 182 
PROPYLENE GLYCOL 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:11410-956-441 TUBE in 1 BOX
115 g in 1 TUBE
2NDC:11410-956-171 TUBE in 1 BOX
245 g in 1 TUBE
3NDC:11410-956-381 TUBE in 1 BLISTER PACK
32 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA02038003/27/2017
Labeler - The Proactiv Company, LLC (080216357)

 
The Proactiv Company, LLC

Medically reviewed on Aug 10, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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