DYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]

DYNASHIELD WITH DIMETHICONE (ZINC OXIDE) OINTMENT [DYNAREX CORPORATION]
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NDC 67777-408-03
Set ID b5dcf9e8-4689-4a08-ae73-3a859b4cbffe
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Zinc Oxide 2%                   Diaper Rash

    Dimethicone 1.8%              Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash
    • 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
    • over large areas of the body
    • if you are allergic to any of these ingredients
  • Keep out of reach of children.

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

  • Dosage and Administration:

               For poison ivy, oak and sumac:

    • Apply ointment liberally as often as needed

               For diaper Rash:

    • change wet and soiled diapers promptly
    • clean the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information:

    • Do not use if seal is punctured or not visible
    • Store at room temperature 15 - 30 C (59 - 86 0 F)
    • avoid excessive heat
    • contains color additives including FDC yellow # 5 (Tartrazine)
  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender perfume, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Trolamine, Vitamin A, Water

  • Principal Display Panel

    Dynarex DynaShield Skin Protectant

    dynashield dimeth.jpg

    Dynashield with Dimethicone

  • INGREDIENTS AND APPEARANCE
    DYNASHIELD WITH DIMETHICONE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-408
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    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)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-408-03114 g in 1 TUBE; Type 0: Not a Combination Product10/01/2014
    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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