DYNASHIELD (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]

DYNASHIELD (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]
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NDC 67777-407-01, 67777-407-02, 67777-407-03, 67777-407-04
Set ID 59fd865c-b81d-43ad-8fa0-c37ca0557769
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    Zinc Oxide 1.8%

  • Purpose

    ​Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Temporarily protects minor • cuts • scrapes • burns
    • Dries the oozing and weeping of poison • ivy • oak • 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 within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
    • For other uses: Apply as needed.
  • Other Information

    • Store at room temperature
    • Avoid excessive heat
  • Inactive Ingredients

    Glycerin USP, Cetostearyl Alcohol USP, Cetyl Alcohol USP, White Petrolatum USP (white soft paraffin), Mineral Oil USP, Anhyudrous Lanolin USP, Cetomacrogol 1000 BP, Aloe vera Extract, Methyl Paraben USP, Propyl Paraben USP, Perfume Lavander K748, Alpha Tocopherol USP, Trolamine USP (Triethanolamine), Vitamin A USP, Cholecalciferol (Vitamin D3) USP, FD&C Yellow No. 5 (tartrazine)

  • Labeling

    DynaShield Label

  • INGREDIENTS AND APPEARANCE
    DYNASHIELD 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-407
    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
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A (UNII: 81G40H8B0T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-407-015 g in 1 PACKET; Type 0: Not a Combination Product05/23/2018
    2NDC:67777-407-0215 g in 1 PACKET; Type 0: Not a Combination Product05/23/2018
    3NDC:67777-407-03114 g in 1 TUBE; Type 0: Not a Combination Product05/23/2018
    4NDC:67777-407-04427.5 g in 1 JAR; Type 0: Not a Combination Product05/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)

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