Your browser does not support JavaScript! X OUT CLEANSING BODY BAR (SALICYLIC ACID) SOAP [GUTHY-RENKER LLC]
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X OUT CLEANSING BODY BAR (salicylic acid) soap
[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

Salicylic Acid 1%

Purpose

Acne Treatment

Use

for the management of acne.

Warnings

For external use only

When using this product

  • 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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

  • 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.
  • 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.

Inactive ingredients

sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, polyethylene, disodium EDTA, pentasodium pentetate, titanium dioxide (CI 77891)

Questions or comments?

Within US 1-800-524-7952

Dist. by: Guthy-Renker® LLC • PO Box 14383 Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 141 g Applicator Carton

X®
OUT

CLEANSING
BODY BAR

From the Makers of Proactiv®

salicylic acid acne treatment
5.0 OZ. • 141 g

Principal Display Panel - 141 g Applicator Carton
X OUT CLEANSING BODY BAR 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM COCOYL ISETHIONATE 
STEARIC ACID 
WATER 
SODIUM ISETHIONATE 
COCAMIDOPROPYL HYDROXYSULTAINE 
SODIUM CHLORIDE 
HIGH DENSITY POLYETHYLENE 
EDETATE DISODIUM 
PENTASODIUM PENTETATE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:11410-007-371 in 1 CARTON
1141 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/31/2012
Labeler - Guthy-Renker LLC (608315453)

Revised: 01/2013
Document Id: 3f824c70-fe77-4e57-8c03-de829a9edd86
Set id: 0fca4d77-c463-4d35-a518-1e3b2be81a70
Version: 1
Effective Time: 20130104
 
Guthy-Renker LLC

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