PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR- benzoyl peroxide lotion 
Guthy-Renker 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+ Skin Smoothing Exfoliator

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11410-011
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
LAURYL/MYRISTYL BENZOATE (UNII: N5RS934G6D)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-011-68 1 in 1 BOX
1 177.4 mL in 1 TUBE
2 NDC:11410-011-22 1 in 1 BOX
2 60 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 01/25/2013
Labeler - Guthy-Renker LLC (608315453)

Revised: 1/2013
Document Id: c82a1fd2-b198-449f-bbdf-95fb8809aaea
Set id: b56b63d6-5635-4fd4-9517-8b08c3cbf9aa
Version: 1
Effective Time: 20130128
 
Guthy-Renker LLC