PROACTIV REPAIRING TREATMENT- 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
Repairing Treatment

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 - DO NOT USE SECTION

Do not use this medication if you

  • have very sensitive skin.
  • are sensitive to benzoyl peroxide.

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.

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with the eyes, lips and mouth.
  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

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

  • cleanse the skin thoroughly before applying this product.
  • 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

  • sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Dist. by Guthy-Renker®
PO Box 14383
Palm Desert, CA 92255-4383
proactiv.com

PRINCIPAL DISPLAY PANEL - 89 mL Carton

Rodan & Fields

proactiv®
SOLUTION

Repairing
Treatment
3

benzoyl peroxide acne treatment

3 FL. OZ. 89 mL

Principal Display Panel – 89 mL Carton
PROACTIV REPAIRING TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-044
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-044-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
2NDC:11410-044-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
3NDC:11410-044-3590 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
4NDC:11410-044-3290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
5NDC:11410-044-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
6NDC:11410-044-8989 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/200912/02/2019
7NDC:11410-044-231 in 1 BOX03/30/200912/02/2019
7NDC:11410-044-2060 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 FINALpart333D03/30/200912/02/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
 
THE PROACTIV COMPANY LLC