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Proactiv Repairing Treatment by Guthy-Renker LLC

Medically reviewed on August 18, 2017

Dosage form: lotion
Ingredients: Benzoyl Peroxide 2.5mg in 100mL
Labeler: Guthy-Renker LLC
NDC Code: 11410-044

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 Treatment

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.
  • 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.

When using this product

  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with the eyes, lips and mouth.
  • 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.

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
  • cleanse the skin thoroughly before applying this product.
  • 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 to once a day or every other day.
  • if going outside, use a sunscreen.

Other information
  • sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.

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)

Dist. by Guthy-Renker®
PO Box 14383
Palm Desert, CA 92255-4383
proactiv.com

PRINCIPAL DISPLAY PANEL - 89 mL Carton

Rodan & Fields

proactiv®
SOLUTION

Repairing
Treatment
3

benzoyl peroxide acne treatment

3 FL. OZ. 89 mL

PROACTIV REPAIRING TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-044
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:11410-044-1030 mL in 1 BOTTLE, PLASTIC
2NDC:11410-044-2060 mL in 1 BOTTLE, PLASTIC
3NDC:11410-044-3590 mL in 1 BOTTLE, PLASTIC
4NDC:11410-044-3290 mL in 1 BOTTLE, PLASTIC
5NDC:11410-044-40120 mL in 1 BOTTLE, PLASTIC
6NDC:11410-044-8989 mL in 1 BOTTLE, PLASTIC
7NDC:11410-044-231 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
7NDC:11410-044-2060 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/30/2009
Labeler - Guthy-Renker LLC (608315453)

 
Guthy-Renker LLC

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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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