Label: BAZA PROTECT- zinc oxide and dimethicone cream

  • NDC Code(s): 11701-046-14, 11701-046-22, 11701-046-23
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 26, 2024

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  • SPL UNCLASSIFIED SECTION

    For Skin Irritation Due to Incontinence

    • Protects
    • Easy to apply and remove
    • Seals out wetness
  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredients

    Zinc Oxide, 12%

    Dimethicone, 1 %

    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
    • apply to 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

    BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

    See crimp for lot no. and expiration date

    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.cobplast.com
    Product #1880 ©2008-7, Coloplast Corp.
    Made in the U.S.A.

    G8-773

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

    NDC 11701-046-14

    Baza®Protect

    Skin Protectant

    Moisture Barrier Cream

    For Skin Irritation Due to Incontinence

    Coloplast

    NET WT. 5 OZ. (142 g)

    PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)
  • INGREDIENTS AND APPEARANCE
    BAZA PROTECT 
    zinc oxide and dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-046-224 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-046-2357 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    3NDC:11701-046-14142 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02206/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-046)
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