KINRAY VITAMIN A D (PETROLATUM) OINTMENT [KINRAY INC.]

KINRAY VITAMIN A D (PETROLATUM) OINTMENT [KINRAY INC.]
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NDC 63777-214-02, 63777-214-07
Set ID 87c76eb4-309a-419a-8d43-5ef4a39d7f2a
Category HUMAN OTC DRUG LABEL
Packager Kinray Inc.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose

    White Petrolatum USP (76%)            Skin Protectant

  • Kinray Uses:

    • 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
  • 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.
  • Do Not Use

    Do not use on:
    Deep or puncture wounds
    animal bites
    serious burns

  • 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

    Kinray.jpg

    Kinray Vit A&D

  • INGREDIENTS AND APPEARANCE
    KINRAY VITAMIN A D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-214
    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:63777-214-02425.25 g in 1 JAR
    2NDC:63777-214-071 in 1 BOX
    2113.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/19/2010
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma India Private Limited918531450manufacture(63777-214)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(63777-214)

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