Label: X-OUT WASH-IN TREATMENT- benzoyl peroxide gel
- NDC Code(s): 11410-117-48, 11410-117-49
- 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 August 30, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Benzoyl Peroxide 8.5%Close
For the management of acneClose
For external use only
When using this product
- skin irritation and dryness is 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 expose and use a sunscreen.
- avoid contact with the eyes, lips and mouth.
- skin irritation may occur, characterized by redness, burning, itching, peeling or possible 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.
use morning and night
- apply to dampened skin and gently massage for 1 to 2 minutes.
- rinse thoroughly with warm water.
- pat dry.
- 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 product and see a doctor.
- do not use product more than three times a day.
- Other information
- sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
- avoid contact with hair and dyed fabrics, which may be bleached by this product.
- Inactive Ingredients
water (aqua), sodium cocoyl isethionate, glycerin, polyethylene, lauryl/myristyl benzoate, linoleic acid, linolenic acid, menthol, butylene glycol, dimethicone, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, phenoxyethanol, fragrance (parfum).Close
- SPL UNCLASSIFIED SECTION
Distributed by Guthy-Renker® LLC, Palm Desert, CA 92260Close
- PRINCIPAL DISPLAY PANEL - 200 g Bottle Label
benzoyl peroxide acne treatment
7.0 OZ. • 200 g
- INGREDIENTS AND APPEARANCE
X-OUT WASH-IN TREATMENT
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 8.5 mg in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) LINOLEIC ACID (UNII: 9KJL21T0QJ) LINOLENIC ACID (UNII: 0RBV727H71) MENTHOL (UNII: L7T10EIP3A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-117-48 75 g in 1 BOTTLE 2 NDC:11410-117-49 200 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 09/23/2011 Labeler - Guthy-Renker LLC (608315453)