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Proactiv Renewing Cleanser by Guthy-Renker LLC

Dosage form: cream
Ingredients: Benzoyl Peroxide 0.025g in 1000mL
Labeler: Guthy-Renker LLC
NDC Code: 11410-927

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 Renewing Cleanser

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 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 skin irritation becomes severe.

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

Directions
  • Use morning and night.
  • Apply a dime-sized amount to damp skin and gently massage for 1 to 2 minutes.
  • Rinse thoroughly with warm water.
  • Pat dry.
  • 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), magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, polyethylene, cetyl esters, anthemis nobilis flower extract, sodium hyaluronate, sodium PCA, xanthan gum, tridecyl trimellitate, propylene glycol, Imidazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

COMBINATION
THERAPY®

benzoyl peroxide acne treatment

1 FL. OZ. 30 mL

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
Renewing
Cleanser

Combination Therapy®

benzoyl peroxide acne treatment

2 FL. OZ. 60 mL

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne treatment

6 FL. OZ. 177 mL

PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-927
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide0.025 g  in 1000 mL
Packaging
#Item CodePackage Description
1NDC:11410-927-40120 mL in 1 BOTTLE, PLASTIC
2NDC:11410-927-421 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
2NDC:11410-927-40120 mL in 1 BOTTLE, PLASTIC
3NDC:11410-927-2060 mL in 1 BOTTLE, PLASTIC
4NDC:11410-927-71177 mL in 1 BOTTLE, PLASTIC
5NDC:11410-927-731 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
5NDC:11410-927-71177 mL in 1 BOTTLE, PLASTIC
6NDC:11410-927-691 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
6NDC:11410-927-70180 mL in 1 BOTTLE, PLASTIC
7NDC:11410-927-70180 mL in 1 BOTTLE, PLASTIC
8NDC:11410-927-1030 mL in 1 BOTTLE, PLASTIC
9NDC:11410-927-80240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/01/2010
PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-923
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide0.025 g  in 1000 mL
Packaging
#Item CodePackage Description
1NDC:11410-923-1030 mL in 1 BOTTLE, PLASTIC
2NDC:11410-923-2060 mL in 1 BOTTLE, PLASTIC
3NDC:11410-923-40120 mL in 1 BOTTLE, PLASTIC
4NDC:11410-923-70180 mL in 1 BOTTLE, PLASTIC
5NDC:11410-923-71177 mL in 1 BOTTLE, PLASTIC
6NDC:11410-923-80240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2010
Labeler - Guthy-Renker LLC (608315453)

Revised: 08/2010
 
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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