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®

2 FL. OZ. 60 mL

benzoyl peroxide acne treatment

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PROACTIV REPAIRING
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-207
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-207-35	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2007	01/01/2019
2	NDC:11410-207-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2007	01/01/2019
3	NDC:11410-207-23	1 in 1 BOX	10/25/2007	01/01/2019
3		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:11410-207-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2007	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	10/25/2007	01/01/2019

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