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zinc oxide (Sion Biotext Medical Ltd)

Available Formats

Dosage Form Package Information Links
OINTMENT 6 BOX in 1 CASE (68786-226-02) > 36 PACKET in 1 BOX > 15 g in 1 PACKET Label Information
OINTMENT 6 BOX in 1 CASE (68786-226-01) > 144 PACKET in 1 BOX > 5 g in 1 PACKET Label Information

Complete zinc oxide Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:68786-226
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.8 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68786-226-01 6 in 1 CASE
    1 144 in 1 BOX
    1 5 g in 1 PACKET
    2 NDC:68786-226-02 6 in 1 CASE
    2 36 in 1 BOX
    2 15 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/01/2010
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Dynarex Corporation (008124359)
    Establishment
    Name Address ID/FEI Business Operations
    Sion Biotext Medical Ltd 532775194 manufacture