ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-011-01, 50382-011-02
Set ID e24b5acd-6094-4d4d-a027-81359133e7a8
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
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.

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

  • Inactive Ingredients

    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

    Galentic GalShield

    GalShield.jpg

    Galentic GalShield

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-011
    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:50382-011-01114 g in 1 TUBE
    2NDC:50382-011-02427.5 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/08/2013
    Labeler - Galentic Pharma (India) Private Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited918531450manufacture(50382-011)

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