Label: ZINC OXIDE ointment

  • 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 September 4, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Zinc Oxide (1.8% w/w)      Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash
    • Temporarily protects
    • minor cuts
    • scrapes and
    • burns
    • dries the oozing and weeping of
    • poison ivy
    • poison oak
    • poison sumac
  • Warnings:

    For External Use Only.

  • When using this product:

    Do not get in eyes.

  • Stop use and ask a doctor if:

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
  • Dosage & Administration

    For skin protectant:
    Apply liberally as needed
    For diaper Rash:
    change wet and soiled diapers promptly
    allow to dry
    apply ointment liberally with each diaper change

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information:

    • Store at room temperature
    • avoid excessive heat
    • contains color additives including FDC yellow # 5
  • Indications & Usage

    Indications: For use as a general skin protectant and diaper rash.

  • Inactive Ingredients

    Inactive ingredients:

    Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water


  • Principle Display Panel

    Geriguard Skin Protectant

    Zinc Oxide Ointment

    zinc_oxide.jpg

    zinc_oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58029-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A (UNII: 81G40H8B0T)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58029-223-0224 in 1 CASE
    1114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2011
    Labeler - Gerimedix Incorporated (153496690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(58029-223)
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