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 January 22, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Zinc Oxide (1.8% w/w)      Skin Protectant

  • Uses:

    • 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
  • Keep out of reach of children.

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

  • Directions:

               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
  • Other information:

    • Store at room temperature
    • avoid excessive heat
    • contains color additives including FDC yellow # 5
  • Principal Display Panel

    Zinc Oxide OintmentZinc Oxide Ointment


  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-226
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-226-016 in 1 CASE
    1144 in 1 BOX
    15 g in 1 PACKET
    2NDC:68786-226-026 in 1 CASE
    236 in 1 BOX
    215 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2010
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Dynarex Corporation (008124359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture
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