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Bedside-Care Perineal Wash (Coloplast Manufacturing US, LLC)

Available Formats

Dosage Form Package Information Links
LIQUID 3.8 L in 1 BOTTLE (11701-059-09) Label Information
LIQUID .237 L in 1 BOTTLE, SPRAY (11701-059-05) Label Information
LIQUID .118 L in 1 BOTTLE, SPRAY (11701-059-04) Label Information

Complete Bedside-Care Perineal Wash Information

  • SPL UNCLASSIFIED SECTION

    For 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, scrapes 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 72 hours, 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 water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, citric acid, quaternium-52, quaternium-15, tetrasodium EDTA

    Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomy/Incontinence Appliance: To help control odor, spray into appliance before and after use.

    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
    Product #1453 ©2009-2, Coloplast Corp.
    Made in the U.S.A.

    B9-1383


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)

    NDC 11701-059-05

    Bedside-Care® Perineal Wash

    Perineal Skin Cleanser

    No-Rinse

    Incontinent Cleanser

    For Perineal Clean-Up

    Coloplast

    NET WT. 8 fl. oz. (237mL)

    PRINCIPAL DISPLAY PANEL - NET WT. 8 fl. oz. (237mL)

  • INGREDIENTS AND APPEARANCE
    BEDSIDE-CARE PERINEAL WASH  
    benzethonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-059
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1 mL  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    QUATERNIUM-52 (UNII: 588EQF3H1P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11701-059-04 0.118 L in 1 BOTTLE, SPRAY
    2 NDC:11701-059-05 0.237 L in 1 BOTTLE, SPRAY
    3 NDC:11701-059-09 3.8 L in 1 BOTTLE
    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