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Bedside-Care Foam (Coloplast Manufacturing US, LLC)

Available Formats

Dosage Form Package Information Links
SHAMPOO 237 mL in 1 BOTTLE, SPRAY (11701-052-05) Label Information
SHAMPOO 118 mL in 1 BOTTLE, SPRAY (11701-052-04) Label Information

Complete Bedside-Care Foam Information

  • SPL UNCLASSIFIED SECTION

    For Full-Body Bathing And Perineal Clean-Up


  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredient

    Benzethonium Chloride 0.1%

    Purpose

    Antiseptic

    Uses Protects against the risk of bacterial contamination in minor cuts, scraps and burns.

    Warnings

    When using this product: do not use in the eyes, with deep or puncture wounds, serious burns, or animal bites.

    Stop using this product:

    • if skin irritation and redness develop
    • if condition persists for more than 7 days, consult a physician.

    For external use only.

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

    Directions Cleanse the affected area according to protocol.

    Inactive ingredients purified water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, fragrance, tetrasodium EDTA, green 5

    Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Cleansing: apply to the affected perineal area and remove with a moist washcloth. Bathing: dispense 3-4 pumps in a basin with warm water and cleanse the skin. Shampooing: pump foam directly on dampened hair, lather and remove with a moist washcloth.

    Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
    Distributed by: Coloplast Corp., Minneapolis, MN 55411 U.S.A.
    1-800-533-0464 www.us.coloplast.com ©2007, Coloplast Corp.
    Product #7145 Made in the U.S.A.

    G7-1276


  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 11701-052-04

    Bedside-Care® Foam

    Bathing & Perineal Skin Cleanser

    No-Rinse Foaming
    Body Wash, Shampoo
    & Incontinent Cleanser

    For Full Body
    Bathing and Perineal
    Clean-Up

    Coloplast

    4 fl. oz. (118 mL)

    Principal Display Panel - 118 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    BEDSIDE-CARE FOAM   (ALCOHOL FREE)
    benzethonium chloride shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-052
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 100 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    QUATERNIUM-52 (UNII: 588EQF3H1P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11701-052-04 118 mL in 1 BOTTLE, SPRAY
    2 NDC:11701-052-05 237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    Name Address ID/FEI Business Operations
    Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-052)