Label: BAZA CLEANSE AND PROTECT ODOR CONTROL- dimethicone lotion

  • NDC Code(s): 11701-062-05
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-062-05227 g in 1 BOTTLE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-062)