Proactiv Solution Extra Strength Formula Lotion

Proactiv by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

PROACTIV   EXTRA STRENGTH FORMULA
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	7 mg  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-304-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2003	12/31/2019
2	NDC: 11410-304-23	1 in 1 BOX	12/01/2003	12/31/2019
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/01/2003	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 7/2010

Document Id: 9720352d-3207-4560-8b9c-d137decf2a03

34390-5

Set id: 5099ebef-0afe-4e99-a7e7-bb45b18ce656

Version: 2

Effective Time: 20100713