Proactiv Solution Renewing Cleanser

Proactiv Renewing Cleanser by

Drug Labeling and Warnings

Proactiv Renewing Cleanser by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV RENEWING 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 Solution Renewing Cleanser

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

OTC - ASK DOCTOR/PHARMACIST SECTION

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. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • keep away from lips and mouth.
  • avoid unnecessary sun exposure and use a sunscreen.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • This product may bleach hair or dyed fabrics.
  • Store at room temperature. Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive Ingredients

water (aqua), magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, disodium PEG-12 dimethicone sulfosuccinate, sorbitol, dimethyl isosorbide, 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 Label

Rodan & Fields

proactiv®
SOLUTION

Renewing
Cleanser

STEP 1

benzoyl peroxide acne treatment

1 FL. OZ. 30 mL

Principal Display Panel
PROACTIV RENEWING CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide0.25 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-409-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200901/01/2019
2NDC: 11410-409-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200901/01/2019
3NDC: 11410-409-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200901/01/2019
4NDC: 11410-409-70180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200901/01/2019
5NDC: 11410-409-421 in 1 CARTON01/01/200901/01/2019
5120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/200901/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
 
THE PROACTIV COMPANY LLC