Label: DYNA1195- zinc oxide ointment

  • 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 October 23, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Zinc Oxide (1.8% w/w)      Skin Protectant

  • Purpose:

    • 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.

  • Dosage and Administration:

               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 (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

    Dyna1195 Skin Protectant

    Dyna1195.jpg

    Dyna1195

  • INGREDIENTS AND APPEARANCE
    DYNA1195 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-226
    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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-226-015 g in 1 PACKET
    2NDC:61767-226-0215 g in 1 PACKET
    3NDC:61767-226-03114 g in 1 TUBE
    4NDC:61767-226-04427.5 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/23/2014
    Labeler - Blossom Pharmaceuticals (677381470)
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