Label: PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR- benzoyl peroxide lotion
- NDC Code(s): 11410-011-22, 11410-011-68
- Packager: Guthy-Renker LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 31, 2016
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Benzoyl peroxide 2.5%Close
Acne treatment gelClose
for the management of acne.Close
For external use only
When using this product
- do not use this product more than three times per day.
- 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 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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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.
- apply a small amount to dampened skin.
- 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.
- 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, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, glycolic acid, sodium hydroxide, phenoxyethanol, fragrance.Close
- Questions or comments?
Within US 1-800-950-4695Close
- SPL UNCLASSIFIED SECTION
Dist. by: Guthy-Renker® LLC • PO Box 14383Close
Palm Desert, CA 92255-4383
- PRINCIPAL DISPLAY PANEL - 60 mL Tube Box
Rodan & Fields
2 FL. OZ. 60 mL
- INGREDIENTS AND APPEARANCE
PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR
benzoyl peroxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-011 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 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 01/25/2013 1 177.4 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11410-011-22 1 in 1 BOX 01/25/2013 2 60 mL in 1 TUBE; 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 01/25/2013 Labeler - Guthy-Renker LLC (608315453)