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

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ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-051-13, 50382-051-14, 50382-051-20
Set ID 45e1d7b2-934c-4de0-a16e-01ecd1c0619e
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • • ACTIVE INGREDIENT

    Zinc Oxide 20%

  • • PURPOSE

    Skin Protectant

  • • USES

    Helps treat and prevent diaper rash

    Protects chafed skin due to diaper rash and helps seal out wetness

  • • WARNINGS

    For external use only.

    • When using this product
      • do not get into 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • • DOSAGE & ADMINISTRATION

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area
    • Allow to dry
    • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • • OTHER INFORMATION

    • Store at 15° to 30° C (59° to 86° F)
    • Lot No. & Exp. Date: See box or crimp of tube
  • • INACTIVE INGREDIENT

    Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

  • SPL UNCLASSIFIED SECTION

    Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Galentic

    Zinc Oxide
    Ointment
    SKIN PROTECTANT

    Helps Heal, Soothe &
    Prevent Diaper Rash

    NET WT.
    1 OZ. (28g)

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-051-131 in 1 CARTON04/04/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50382-051-141 in 1 CARTON04/04/2013
    256 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50382-051-2012 in 1 CASE04/04/2013
    3425 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/04/2013
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-051) , manufacture(50382-051) , pack(50382-051) , sterilize(50382-051)
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