Proactiv Repairing

Dosage form: lotion
Ingredients: Benzoyl Peroxide 2.5mg in 100mL
Labeler: Guthy-Renker LLC
NDC Code: 11410-207

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 Solution Repairing Lotion

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • keep away from lips and mouth
  • avoid unnecessary sun exposure and use a sunscreen

Stop use and ask a doctor if skin irritation occurs.

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

Directions
  • Cleanse the skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application use to once a day or every other day.
  • If going outside, use a sunscreen.

Other information
  • This product may bleach hair or dyed fabrics.

Inactive Ingredients

water (aqua), ethoxydiglycol, cyclotetrasiloxane, propylene glycol, cetearyl alcohol, dimethicone, glyceryl stearate, PEG-100 stearate, cyclopentasiloxane, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, triethanolamine, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

Combination Therapy®

3

2 FL. OZ. 60 mL

benzoyl peroxide acne treatment

PROACTIV REPAIRING 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-207
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide2.5 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:11410-207-3590 mL in 1 BOTTLE, PLASTIC
2NDC:11410-207-2060 mL in 1 BOTTLE, PLASTIC
3NDC:11410-207-231 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
360 mL in 1 BOTTLE, PLASTIC
4NDC:11410-207-1030 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/25/2007
Labeler - Guthy-Renker LLC (608315453)

Revised: 05/2010
 
Guthy-Renker LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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