Label: DYNASHIELD WITH DIMETHICONE- zinc oxide cream

  • NDC Code(s): 67777-408-02, 67777-408-03
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL

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 May 9, 2023

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  • Active Ingredients

    Zinc Oxide 2%

    Dimethicone 1.8%

  • Purpose

    • Diaper rash
    • Skin Protectant
  • Uses

    • Use as a general skin protectant

    • Helps treat chafed skin associated with diaper rash

    • Dries the oozing and weeping of poison ivy, oak, and sumac

  • Warnings

    For External Use Only.

    When using this product:

    • Avoid contact with eyes

    • Do not use over large areas of the body

    • So not use if you are allergic to any of the ingredients

    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 (1-800-222-1222) right away.

  • Directions

    • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream 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 between 15 0 - 30 0 C (59 0 - 86 0 F)

    • Avoid excessive heat

    • Tamper evident. Do not use if seal is damaged.

  • Inactive Ingredients

    Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Tartrazine, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Soft Paraffin

  • Questions and Comments?

    1-888-396-2739, Monday - Friday 9AM-5PM EST

  • Label

    1199 IN MASTERDynaShield with Dimehticone

  • INGREDIENTS AND APPEARANCE
    DYNASHIELD WITH DIMETHICONE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-408
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-408-0224 in 1 CASE10/01/2014
    1NDC:67777-408-03114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/01/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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