X OUT CLEANSING BODY (SALICYLIC ACID) SOAP [BRADFORD SOAP WORKS, INC.]

X OUT CLEANSING BODY (SALICYLIC ACID) SOAP [BRADFORD SOAP WORKS, INC.]
PDF | XML

NDC 11118-0119-1
Set ID dd1389ed-8589-4796-992c-fb4bd6d3e84e
Category HUMAN OTC DRUG LABEL
Packager Bradford Soap Works, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
  • Drug FactsActive 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

  • INGREDIENTS AND APPEARANCE
    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) , label(11118-0119)

Related Drugs