Label: DYNASHIELD- zinc oxide cream

  • NDC Code(s): 67777-407-01, 67777-407-02, 67777-407-03, 67777-407-04, view more
    67777-407-10, 67777-407-11
  • Packager: Dynarex Corporation
  • 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 May 9, 2023

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  • Active Ingredient

    Zinc Oxide 1.8%

  • Purpose

    ​Skin Protectant

  • Uses

    • Helps treat chafed skin associated with 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 (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 15º-30ºC (59°-86°F)
    • Avoid excessive heat
    • Tamper evident. Do not use if seal is damaged.
  • Inactive Ingredients

    Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, White Soft Paraffin, Mineral Oil, Lanolin, Cetomacrogol 1000, Aloe Vera Leaf, Methyl Paraben, Propyl Paraben, Perfume Lavander Oil, Alpha Tocopherol, Trolamine, Vitamin A Acetate, Cholecalciferol (Vitamin D3), FD&C Yellow No. 5 (Tartrazine), Water

  • 1195 Label

    1195 IN MASTER

  • 1196 Label

    1196 IN MASTER

  • INGREDIENTS AND APPEARANCE
    DYNASHIELD 
    zinc oxide cream
    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
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    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:67777-407-1024 in 1 CASE10/01/2014
    3NDC:67777-407-03114 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:67777-407-1112 in 1 CASE10/01/2014
    4NDC:67777-407-04427.5 g in 1 JAR; 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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