X OUT CLEANSING BODY- salicylic acid soap 
Bradford Soap Works, Inc.

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 - 0119

Drug Facts
Active ingredient

Salicylic acid 1%

Purpose

Acne treatment

Keep out of reach of children.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Use

for the management of acne

Warnings

For external use only

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

Stop use and ask a doctor if

  • irritation becomes severe.

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. 

Inactive ingredients

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

Questions or comments?

Within the US 1-800-524-7952

X OUT CLEANSING BODY BAR product label

Drug Facts

Active ingredient……………….….Purpose

Salicylic acid 1%..................Acne Treatment

Use for management of acne

Warnings

For external use only

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 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

•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.

X OUT

CLEANSING BODY BAR

From the Makers of Proactiv®

Salicylic acid acne treatment

5.0 OZ. • 141 g

Drug Facts (continued)

Inactive ingredients sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentetrate, titanium dioxide

Questions or comments:

Within the US 1-800-524-7952

Distributed by The Proactiv Company LLC • 100 N Seplveda Blvd. El Segundo, CA 90245

XOut.com • Mae in the USA of Foreign and Domestic Components. XOut is a trademark of The Proactiv Company SanL       DT0063  DTBOXD19

7   35786 02062   0

Bradford XOut

X OUT CLEANSING BODY 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11118-0119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.001 g  in 0.1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GALACTOARABINAN (UNII: SL4SX1O487)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11118-0119-1141 g in 1 PACKAGE; Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/01/2016
Labeler - Bradford Soap Works, Inc. (001201045)
Registrant - Bradford Soap Works, Inc. (001201045)
Establishment
NameAddressID/FEIBusiness Operations
Bradford Soap Works, Inc.001201045manufacture(11118-0119)

Revised: 11/2022
 
Bradford Soap Works, Inc.