Your browser does not support JavaScript! X-OUT WASH-IN TREATMENT (BENZOYL PEROXIDE) GEL [GUTHY-RENKER LLC]
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X-OUT WASH-IN TREATMENT (benzoyl peroxide) gel
[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 8.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

Do not use this medication if you

  • have very sensitive skin.
  • are sensitive to benzoyl peroxide.

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.

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

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).

Distributed by Guthy-Renker® LLC, Palm Desert, CA 92260

PRINCIPAL DISPLAY PANEL - 200 g Bottle Label

X
OUT

WASH-IN
TREATMENT

benzoyl peroxide acne treatment
7.0 OZ. • 200 g

Principal Display Panel - 200 g Bottle Label
X-OUT WASH-IN TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11410-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide8.5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM COCOYL ISETHIONATE 
GLYCERIN 
HIGH DENSITY POLYETHYLENE 
LINOLEIC ACID 
LINOLENIC ACID 
MENTHOL 
BUTYLENE GLYCOL 
DIMETHICONE 
ETHYLHEXYLGLYCERIN 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-117-4875 g in 1 BOTTLE
2NDC:11410-117-49200 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D09/23/2011
Labeler - Guthy-Renker LLC (608315453)

Revised: 8/2011
 
Guthy-Renker LLC

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