Label: MAX BARRIER SKIN PROTECTANT- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 26, 2024

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  • Drug Facts

  • Active ingredients

    Zinc Oxide 40%

    Purpose

    Skin Protectant

  • Uses

    • Protects chafed skin due to wetness and helps seal out wetness
    • Helps treat and prevent diaper rash
  • Warnings

    For external use only

    When using this product

    avoid contact with the eyes

    Stop use and talk to a doctor if

    condition worsens or does not improve after 7 days

    Keep out of the reach of children

    If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately

  • Directions

    Apply a layer of the skin protectant to the area you wish to protect. For diaper rash prevention, change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.

  • Inactive ingredients

    Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)

  • Questions?

    Call 1-708-381-0334

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MAX BARRIER SKIN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82897-468
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION400 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82897-468-003.3 mL in 1 PACKET; Type 0: Not a Combination Product03/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/08/2024
    Labeler - GL HEALTH, INC. (086010932)
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