PROACTIV SOLUTION REPAIRING TREATMENT- benzoyl peroxide gel
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

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment gel

Use

for the management of acne.

Warnings

For external use only

When using this product

skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
avoid unnecessary sun exposure and use a sunscreen.
avoid contact with the eyes, lips, and mouth.
avoid contact with hair and dyed fabrics, which may be bleached by this product.
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.

Do not use if you

have very sensitive skin
are sensitive to benzoyl peroxide

Stop use and ask a doctor

if 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 this product.
cover the entire affected area with a thin layer one to three times daily.
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

water, ethoxydiglycol, cyclotetrasiloxane, cyclopentasiloxane, cetearyl alcohol, dimethicone, glyceryl stearate, peg-100 stearate, propylene glycol, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-950-4695

Dist. by: Guthy-Renker® LLC • PO Box 14383 • Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

3
REPAIRING
TREATMENT

benzoyl peroxide acne treatment

4 FL. OZ. 120 mL

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

PROACTIV SOLUTION REPAIRING TREATMENT
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-955
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)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-955-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2013	12/31/2019
2	NDC:11410-955-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2013	12/31/2019
3	NDC:11410-955-89	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2013	12/31/2019
4	NDC:11410-955-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2013	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	11/01/2013	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 10/2013

Document Id: 025150d1-fd4e-44ae-91a4-2dac68683095

Set id: bdb2fe0a-ffd7-44a0-849c-526b92557646

Version: 2

Effective Time: 20131016

THE PROACTIV COMPANY LLC