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Baza Cleanse and Protect Odor Control (Coloplast Manufacturing US, LLC)

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LOTION 227 g in 1 BOTTLE (11701-062-05) Label Information

Complete Baza Cleanse and Protect Odor Control Information

  • SPL UNCLASSIFIED SECTION

    For At-Risk Skin Due to Incontinence


  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredient

    Dimethicone, 2%

    Purpose

    Diaper Rash Skin Protectant

    Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

    Warnings

    When using this product

    • avoid contact with eyes
    • not to be applied over deep or puncture wounds or lacerations.

    Consult a doctor

    • if condition worsens or does not improve within 7 days.

    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 right away.

    Directions

    • change wet and soiled diapers promptly
    • spray affected area and gently wipe with clean, soft cloth
    • apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

    Inactive ingredients allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, fragrance, glycerin, glyceryl stearate, isopropyl palmitate, metfiylparaben, panthenol, propylene glycol, propylparaben, sodium laurovl lactvlate. soybean oil. tocoDhervl acetate (vitamin B. water, zinc ricinoleate

    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 #7725
    ©2008-9, Coloplast Corp. Made in the U.S.A

    J8-1222


  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

    NDC 11701-062-05

    Baza Cleanse & Protect® Odor Control

    Skin Protectant

    All-In-One Perineal Lotion With Odor Control

    For At-Risk Skin Due to Incontinence

    Coloplast

    8 FL. OZ. (237 mL)

    PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

  • INGREDIENTS AND APPEARANCE
    BAZA CLEANSE AND PROTECT ODOR CONTROL 
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-062
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ZINC RICINOLEATE (UNII: BOH1Z111J2)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11701-062-05 227 g in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 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(11701-062)