Label: BAZA PROTECT- zinc oxide and dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 3, 2020

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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 FINALpart34704/06/2020
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-082)
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