X-Out Wash-In Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

X-Out Wash-In Treatment

Guthy-Renker LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
X Out Wash-In Treatment

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 Type Human otc drug label Item Code (Source) NDC:11410-117
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 8.5 mg

Inactive Ingredients

Ingredient Name Strength
water
SODIUM COCOYL ISETHIONATE
GLYCERIN
HIGH DENSITY POLYETHYLENE
LINOLEIC ACID
LINOLENIC ACID
MENTHOL
BUTYLENE GLYCOL
DIMETHICONE
ETHYLHEXYLGLYCERIN
SODIUM HYDROXIDE
PHENOXYETHANOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-117-48 75 in 1 BOTTLE
2 NDC:11410-117-49 200 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-09-23


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