PROACTIV REPAIRING TREATMENT- benzoyl peroxide gel 
The Proactiv Company, LLC

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.

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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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label
PROACTIV REPAIRING TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-040-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/201701/22/2020
2NDC:11410-040-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/201701/22/2020
3NDC:11410-040-3289 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/201701/22/2020
4NDC:11410-040-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/201701/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/10/201701/22/2020
Labeler - The Proactiv Company, LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 3/2017
Document Id: ffd90cdf-6e44-4d94-af7e-3f752da41b4d
Set id: fc67798f-9027-4704-a9fb-c2c55958de05
Version: 2
Effective Time: 20170313
 
The Proactiv Company, LLC