ZINC OXIDE OINTMENT [SION BIOTEXT MEDICAL LTD]

ZINC OXIDE OINTMENT [SION BIOTEXT MEDICAL LTD]
PDF | XML

NDC 68786-226-01, 68786-226-02
Set ID 03d9cab3-ea90-47f6-9209-0e6622ec50e3
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Zinc Oxide (1.8% w/w)      Skin Protectant

  • Uses:

    • 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.

  • Directions:

               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
  • Principal Display Panel

    Zinc Oxide OintmentZinc Oxide Ointment


  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-226
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-226-016 in 1 CASE
    1144 in 1 BOX
    15 g in 1 PACKET
    2NDC:68786-226-026 in 1 CASE
    236 in 1 BOX
    215 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2010
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Dynarex Corporation (008124359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture

Related Drugs