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X-Out Wash-In Treatment

Dosage form: gel
Ingredients: Benzoyl Peroxide 8.5mg in 100g
Labeler: THE PROACTIV COMPANY LLC
NDC Code: 11410-117

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.

X Out Wash-In Treatment

Drug Facts

Active Ingredient

Benzoyl Peroxide 8.5%

Purpose

Acne treatment gel

Use

For the management of acne

Warnings

For external use only

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

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.

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
  • 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 below.
  • 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, Paraffin, Lauryl/Myristyl Benzoate, Coconut Acid, Linoleic Acid, Linolenic Acid, Menthol, Sodium Isethionate, Butylene Glycol, Dimethicone, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Phenoxyethanol, Fragrance

Questions or comments?
Within US 1-800-524-7952

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245
XOut.com ‚óŹ Made in the USE of foreign and domestic components.
X Out is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 75 g Bottle Label

X
OUT

WASH-IN
TREATMENT

From the Makers of Proactiv®

benzoyl peroxide acne treatment
 2.5 OZ. • 75 g

X-OUT WASH-IN TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem 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 
LINOLEIC ACID 
LINOLENIC ACID 
MENTHOL 
BUTYLENE GLYCOL 
DIMETHICONE 
ETHYLHEXYLGLYCERIN 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
Paraffin 
Lauryl/myristyl Benzoate 
Coconut Acid 
Sodium Isethionate 
Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) 
Packaging
#Item CodePackage Description
1NDC:11410-117-4875 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D09/23/2011
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIOperations
VEE PAK, LLC874763303manufacture(11410-117)

Revised: 12/2017
 
THE PROACTIV COMPANY LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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