Proactiv Solution Repairing Lotion

Proactiv Repairing by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROACTIV REPAIRING- 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 Lotion

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 or if you are sensitive to benzoyl peroxide.

OTC - ASK DOCTOR 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.

When using this product

  • avoid contact with eyes. If contact occurs, rinse 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

  • 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 use to once a day or every other day.
  • If going outside, use a sunscreen.

Other information

  • This product may bleach hair or dyed fabrics.

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)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

Combination Therapy®

3

2 FL. OZ. 60 mL

benzoyl peroxide acne treatment

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
PROACTIV REPAIRING 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-207
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: 11410-207-3590 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/200701/01/2019
2NDC: 11410-207-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/200701/01/2019
3NDC: 11410-207-231 in 1 BOX10/25/200701/01/2019
360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC: 11410-207-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/200701/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/25/200701/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: a2b2fbe0-f8af-47db-a044-25e51b27c88c
Set id: 983be8a4-0ebb-4cb7-bcb0-3396b44ee060
Version: 2
Effective Time: 20200109
 
THE PROACTIV COMPANY LLC