Your browser does not support JavaScript! PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]
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PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (benzoyl peroxide) lotion
[Guthy-Renker LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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.
  • ski 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

  • apply a small amount to dampened skin and gently massage for 1 to 2 minutes
  • cover the entire affected area with a thin layer and rinse thoroughly 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.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
  • 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, sodium cocoyl isethionate, glycerin, polyethylene, lauryl/myristyl benzoate, linoleic acid, linolenic acid, butylene glycol, dimethicone, ehtylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, glycolic acid, sodium hydroxide, phenoxyethanol, 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 - 60 mL Tube Carton

Rodan & Fields
proactiv+

Skin
Smoothing
Exfoliator

2 FL. OZ. 60 mL

benzoyl peroxide
acne treatment

Principal Display Panel - 60 mL Tube Carton
PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11410-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM COCOYL ISETHIONATE 
GLYCERIN 
HIGH DENSITY POLYETHYLENE 
LAURYL/MYRISTYL BENZOATE 
LINOLEIC ACID 
LINOLENIC ACID 
BUTYLENE GLYCOL 
DIMETHICONE 
ETHYLHEXYLGLYCERIN 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCOLIC ACID 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-011-681 in 1 BOX
1177.4 mL in 1 TUBE
2NDC:11410-011-221 in 1 BOX
260 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/25/2013
Labeler - Guthy-Renker LLC (608315453)

Revised: 1/2013
 
Guthy-Renker LLC

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