PROACTIV SOLUTION RENEWING CLEANSER- benzoyl peroxide lotion

Proactiv Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Recommended purpose or Use

Prevents and kills acne bacteria. Reduces the number and/or severity of acne pimples.

Warnings

For external use only. Mild irritation may be reduced by less frequent use.

If excess irritation occurs, discontinue use. If irritation persists, consult a physician.

Keep away from eyes, lips, mouth and nostrils. If contact occurs, rinse thoroughly with water. Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care practitioner. This product may bleach hair or dyed fabrics.

Keep out of reach of children.

Keep from heat.

Directions

• Use morning and night or as directed by a physician (fair skinned individuals should begin with one application).
• Pour small amount into cleansed palm and apply to dampened skin. Massage gently for one to two minutes.
• Rinse thoroughly with warm water, pat dry.
• For more severe cases, and/or if substantial improvement is not apparent within 3-4 weeks, consult a health care practitioner.

Inactive Ingredients

water, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, neopentyl glycol dicaprylate/dicaprate, tridecyl stearate, polyethylene, cetyl esters, anthemis nobilis flower extract, tridecyl trimellitate, , imidazolidinyl urea, sodium PCA, propylene glycol, sodium hyaluronate, xanthan gum, methylparaben, propylparaben, fragrance

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Manufactured in U.S.A. for
Guthy-Renker®, Palm Desert, CA 92240

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne cleanser

DIN: 02239398

4 FL. OZ. 120 mL

INGREDIENTS AND APPEARANCE

PROACTIV SOLUTION  RENEWING CLEANSER
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-901
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITOL (UNII: 506T60A25R)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-901-40	120 mL in 1 BOTTLE, GLASS
2	NDC: 11410-901-71	177 mL in 1 BOTTLE, PLASTIC
3	NDC: 11410-901-20	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/01/2012

Labeler - Guthy-Renker LLC (608315453)