PROACTIV SOLUTION RENEWING CLEANSER- benzoyl peroxide lotion 
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 Solution Renewing Cleanser

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Recommended purpose or Use

OTC - PURPOSE SECTION

Prevents and kills acne bacteria. Reduces the number and/or severity of acne pimples.

Warnings

For external use only. Mild irritation may be reduced by less frequent use.

OTC - STOP USE SECTION

If excess irritation occurs, discontinue use. If irritation persists, consult a physician.

OTC - WHEN USING SECTION

Keep away from eyes, lips, mouth and nostrils. If contact occurs, rinse thoroughly with water. Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care practitioner. This product may bleach hair or dyed fabrics.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Keep from heat.

Directions

  • Use morning and night or as directed by a physician (fair skinned individuals should begin with one application).
  • Pour small amount into cleansed palm and apply to dampened skin. Massage gently for one to two minutes.
  • Rinse thoroughly with warm water, pat dry.
  • For more severe cases, and/or if substantial improvement is not apparent within 3-4 weeks, consult a health care practitioner.

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

Manufactured in U.S.A. for
Guthy-Renker®, Palm Desert, CA 92240

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne cleanser

DIN: 02239398

4 FL. OZ. 120 mL

Principal Display Panel - 120 mL Bottle Label
PROACTIV SOLUTION  RENEWING CLEANSER
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-901
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)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-901-40120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/01/201201/01/2019
2NDC:11410-901-71177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201201/01/2019
3NDC:11410-901-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201201/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/01/201201/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: 0f7e544d-6e75-414b-b022-ccbc1f73c546
Set id: cbec7df1-2e60-4edf-a9d9-3b1cbd4315c3
Version: 2
Effective Time: 20200115
 
THE PROACTIV COMPANY LLC