PROACTIV  EXTRA STRENGTH FORMULA- 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 Extra Strength Formula Lotion

Drug Facts

Active Ingredient

Benzoyl Peroxide 7%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

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.

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

Stop use and ask a doctor if skin irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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, use a sunscreen.

Other information

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

Inactive Ingredients

water (aqua), cyclotetrasiloxane, ethoxydiglycol, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, cyclopentasiloxane, panthenol, allantoin, carbomer, ceteareth-20, xanthan gum, triethanolamine, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum).

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton

Rodan & Fields

proactiv®
SOLUTION

EXTRA STRENGTH
FORMULA

lotion

3

benzoyl peroxide acne treatment

2 FL. OZ. 60 mL

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton
PROACTIV   EXTRA STRENGTH FORMULA
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-304
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-304-1030 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/200312/31/2019
2NDC:11410-304-231 in 1 BOX12/01/200312/31/2019
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/200312/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010
Document Id: 9720352d-3207-4560-8b9c-d137decf2a03
Set id: 5099ebef-0afe-4e99-a7e7-bb45b18ce656
Version: 2
Effective Time: 20100713
 
THE PROACTIV COMPANY LLC