GALENTIC VITAMIN A D (PETROLATUM) OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]

GALENTIC VITAMIN A D (PETROLATUM) OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]
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NDC 50382-003-01, 50382-003-02, 50382-003-03, 50382-003-04
Set ID a56cf1f3-e64a-455c-ac8e-22403970cb0f
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Priva Te Limited
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose

    White Petrolatum USP (76%)            Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and help relieve chapped and cracked skin and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
    • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
    • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
  • Warnings:

    For External Use Only

  • When using this product:

    • Do not get in eyes
  • Stop use and ask a doctor if:

    • If condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
  • Do not use:

    Do not use:

    • Deep or puncture wounds
    • animal bites
    • serious burns
  • 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.
  • Directions for diaper rash:

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply as needed
  • Other information:

    • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
    • Avoid excessive heat
  • Inactive Ingredients:

    Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D

  • Principal Display Panel

    Galentic Vit AD.jpg

    Galentic Vit AD

  • INGREDIENTS AND APPEARANCE
    GALENTIC VITAMIN A D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.76 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-003-01113.4 g in 1 TUBE
    2NDC:50382-003-02425.25 g in 1 JAR
    3NDC:50382-003-0328.35 g in 1 TUBE
    4NDC:50382-003-0456.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-003)

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