PROACTIV SOLUTION RENEWING CLEANSER- benzoyl peroxide gel 
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® 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

Distributed by The Proactiv Company LLC • 100 N Sepulveda Blvd., El Segundo CA 90245

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

proactiv®

CLEANSE

1

RENEWING
CLEANSER

4 FL. OZ. 120 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label
PROACTIV SOLUTION RENEWING CLEANSER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITOL (UNII: 506T60A25R)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-904-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/201106/30/2019
2NDC:11410-904-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/201106/30/2019
3NDC:11410-904-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/201106/30/2019
4NDC:11410-904-71177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/201106/30/2019
5NDC:11410-904-80240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/201106/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/21/201106/30/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-904)

Revised: 4/2019
Document Id: 72c0835b-24ae-47f0-acc2-629594daacfd
Set id: 3e0b90b2-f2d9-4047-aedd-098031944ff4
Version: 4
Effective Time: 20190423
 
THE PROACTIV COMPANY LLC