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Proactiv Renewing Cleanser by The Proactiv Company, LLC

Medically reviewed on November 30, 2017

Dosage form: gel
Ingredients: Benzoyl Peroxide 2.5g in 100mL
Labeler: The Proactiv Company, LLC
NDC Code: 11410-005

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® Renewing Cleanser

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
  • do not use this product more than three times per day.
  • 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 product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • apply a small amount to dampened skin.
  • cover the entire affected area with a thin layer and rinse thoroughly 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 application to once a day or every other day.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

water, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, paraffin, cetyl esters, anthemis nobilis flower extract, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, sodium sulfate, sodium hyaluronate, propylene glycol, sodium PCA, xanthan gum, phenoxyethanol, imidazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245 ‚óŹ proactive.com
Made in the USA of foreign and domestic components

Proacitv is a trademark of The Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv®                 

CLEANSE

1

RENEWING
CLEANSER

 2 FL. OZ. 60 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL CARTON

proactiv®

CLEANSE
1
RENEWING
CLEANSER
6 FL. OZ. 177 mL

benzoyl peroxide acne medication

PROACTIV RENEWING CLEANSER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MAGNESIUM ALUMINUM SILICATE 
Glyceryl Monostearate 
Peg-100 Stearate 
Sorbitol 
Dimethyl Isosorbide 
Tridecyl Stearate 
Neopentyl Glycol Dicaprylate/dicaprate 
Paraffin 
Cetyl Esters Wax 
Chamaemelum Nobile Flower 
Tridecyl Trimellitate 
Trisodium Sulfosuccinate 
Peg-12 Dimethicone (300 Cst) 
Sodium Sulfate 
Hyaluronate Sodium 
Propylene Glycol 
Sodium Pyrrolidone Carboxylate 
Xanthan Gum 
Phenoxyethanol 
Imidurea 
Methylparaben 
Propylparaben 
Disodium Laureth-12 Sulfosuccinate 
Packaging
#Item CodePackage Description
1NDC:11410-005-001 BOTTLE, PLASTIC in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
2NDC:11410-005-051 BOTTLE, PLASTIC in 1 CARTON
2120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/07/2017
Labeler - The Proactiv Company, LLC (080216357)
Establishment
NameAddressID/FEIOperations
VEE PAK, LLC874763303manufacture(11410-005)

 
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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