ZINC OXIDE OINTMENT [DYNAREX CORPORATION]

ZINC OXIDE OINTMENT [DYNAREX CORPORATION]
PDF | XML

NDC 67777-226-01, 67777-226-02, 67777-226-03, 67777-226-04
Set ID 049b727b-6abd-410c-a5d8-7b9c0fdfdbeb
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • 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
  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water


  • Principal Display Panel

    Dynarex DynaShield Skin Protectant

    zinc_oxide.jpg

    zonc_oxide

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-226
    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-10 (UNII: LF9X1PN3XJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    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:67777-226-01144 in 1 BOX
    15 g in 1 PACKET
    2NDC:67777-226-0236 in 1 BOX
    215 g in 1 PACKET
    3NDC:67777-226-0324 in 1 CASE
    3114 g in 1 TUBE
    4NDC:67777-226-04427.5 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)

Related Drugs