Label: BAZA PROTECT- zinc oxide and dimethicone cream

  • NDC Code(s): 11701-082-03, 11701-082-22, 11701-082-24
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide, 12%
    Dimethicone, 1%

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects chafed, chapped or cracked skin.
    • Helps seal out wetness.
  • Warnings

    For external use only.

    When using this product

    • Do not get into eyes.
    • Do not use on:
      • deep or puncture wounds
      • animal bites
      • serious burns.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to affected area and gently wipe with clean, soft cloth.
    • Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged.
  • Inactive ingredients

    Water, petrolatum, lanolin oil, propylene glycol, PEG- 40 stearate, cetyl alcohol, PEG-8 stearate, glyceryl stearate, triacontanyl PVP, fragrance, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, propanediol, tocopheryl acetate, EDTA

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark

    Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Label

    NDC 11701-082-24

    Baza® Protect

    Skin Protectant

    Moisture
    Barrier Cream

    For Skin Irritation
    Due to Incontinence

    Coloplast

    NET WT. 5 OZ. (142 g)

    PRINCIPAL DISPLAY PANEL - 142 g Tube Label
  • INGREDIENTS AND APPEARANCE
    BAZA PROTECT 
    zinc oxide and dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-082
    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
    Water (UNII: 059QF0KO0R)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Lanolin Oil (UNII: OVV5IIJ58F)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    PEG-40 stearate (UNII: ECU18C66Q7)  
    cetyl alcohol (UNII: 936JST6JCN)  
    PEG-8 stearate (UNII: 2P9L47VI5E)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Tricontanyl Povidone (UNII: N0SS3Q238D)  
    Caprylyl glycol (UNII: 00YIU5438U)  
    Caprylhydroxamic acid (UNII: UPY805K99W)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Propanediol (UNII: 5965N8W85T)  
    .alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-082-24142 g in 1 TUBE; Type 0: Not a Combination Product04/06/2020
    2NDC:11701-082-0357 g in 1 TUBE; Type 0: Not a Combination Product04/06/2020
    3NDC:11701-082-224 g in 1 PACKET; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01604/06/2020
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-082)
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