PROACTIV  EXTRA STRENGTH FORMULA CLEANSER- benzoyl peroxide cream 
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 Extra Strength Formula Cleanser
benzoyl peroxide acne medication

Active Ingredient

Benzoyl Peroxide 7%

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 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 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 on the right.
  • 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, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, polyethylene, cetyl esters, tridecyl trimellitate, anthemis nobilis flower extract, sodium hyaluronate, sodium PCA, propylene glycol, xanthan gum, oxidized polyethylene, trisodium sulfosuccinate, PEG-12 dimethicone, sodium sulfate, imidazolidinyl urea, methylparaben, propylparaben, fragrance, ferric ammonium ferrocyanide

Questions or comments?
Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactive.com
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

proactiv®

EXTRA STRENGTH
FORMULA

cleanser

1

benzoyl peroxide acne medication

4 FL. OZ. 120 mL

Proactiv Extra Strength Cleanser Carton
PROACTIV   EXTRA STRENGTH FORMULA CLEANSER
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE7 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethyl Isosorbide (UNII: SA6A6V432S)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Peg-100 Stearate (UNII: YD01N1999R)  
Sorbitol (UNII: 506T60A25R)  
Tridecyl Stearate (UNII: A8OE252M6L)  
Neopentyl Glycol Dicaprylate/dicaprate (UNII: VLW429K27K)  
High Density Polyethylene (UNII: UG00KM4WR7)  
Cetyl Esters Wax (UNII: D072FFP9GU)  
Tridecyl Trimellitate (UNII: FY36J270ES)  
Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Xanthan Gum (UNII: TTV12P4NEE)  
Trisodium Sulfosuccinate (UNII: 085WB9L09N)  
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)  
Sodium Sulfate (UNII: 0YPR65R21J)  
Imidurea (UNII: M629807ATL)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Ferric Ammonium Ferrocyanide (UNII: 9R0NVI936I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-302-151 in 1 CARTON12/01/200312/02/2019
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/200312/02/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-302)

Revised: 12/2017
 
THE PROACTIV COMPANY LLC