X OUT CLEANSING BODY BAR- salicylic acid soap 
Guthy-Renker LLC

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.

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X® Out Cleansing Body Bar

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11410-007
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mg  in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-007-37 1 in 1 CARTON
1 141 g in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 12/31/2012
Labeler - Guthy-Renker LLC (608315453)

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