Label: BEDSIDE-CARE PERINEAL WASH- benzethonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated June 30, 2011

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-059-040.118 L in 1 BOTTLE, SPRAY
    2NDC:11701-059-050.237 L in 1 BOTTLE, SPRAY
    3NDC:11701-059-093.8 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE
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