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Proactiv Repairing Treatment by The Proactiv Company, LLC

Medically reviewed on Mar 13, 2017

Dosage form: gel
Ingredients: Benzoyl Peroxide 2.5mg in 100mL
Labeler: The Proactiv Company, LLC
NDC Code: 11410-040

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Proactiv® Repairing Treatment

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment gel

Use

for the management of acne

Warnings

For external use only

When using this product
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with the eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use and ask a doctor if
  • irritation becomes severe.

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

Directions
  • Sensitivity Test for a New User: Apply sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce use to once a day or every other day.
  • if going outside, apply sunscreen. If irritation or sensitivity develops, stop use and ask a doctor.

Inactive ingredients

water, ethoxydiglycol, cyclotetrasiloxane, cyclopentasiloxane, propylene glycol, cetearyl alcohol, dimethicone, glyceryl stearate, PEG-100 stearate, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben, fragrance

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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

proactiv®

REPAIR

3

REPAIRING
TREATMENT

4 FL. OZ. 120 mL

benzoyl peroxide acne medication

PROACTIV REPAIRING TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLENE GLYCOL MONOETHYL ETHER 
CYCLOMETHICONE 4 
CYCLOMETHICONE 5 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
PROPYLENE GLYCOL 
PANTHENOL 
ALLANTOIN 
XANTHAN GUM 
POLYOXYL 20 CETOSTEARYL ETHER 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
SODIUM HYDROXIDE 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:11410-040-1030 mL in 1 BOTTLE, PLASTIC
2NDC:11410-040-2060 mL in 1 BOTTLE, PLASTIC
3NDC:11410-040-3289 mL in 1 BOTTLE, PLASTIC
4NDC:11410-040-40120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/10/2017
Labeler - The Proactiv Company, LLC (080216357)

 
The Proactiv Company, LLC

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Further information

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

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