Label: KINRAY VITAMIN A D- petrolatum ointment

  • NDC Code(s): 63777-214-02, 63777-214-07
  • Packager: Kinray Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/14

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  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose

    White Petrolatum USP (76%)            Skin Protectant

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  • 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
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  • Warnings:

    For External Use Only

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  • When using this product:

    • Do not get in eyes
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  • 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
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  • 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.
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  • Do Not Use

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

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  • Directions for diaper rash:

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

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

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

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  • Principal Display Panel

    Kinray.jpg

    Kinray Vit A&D

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  • INGREDIENTS AND APPEARANCE
    KINRAY VITAMIN A D 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63777-214
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM .76 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    VITAMIN A PALMITATE  
    LANOLIN  
    LIGHT MINERAL OIL  
    CHOLECALCIFEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63777-214-02 425.25 g in 1 JAR
    2 NDC:63777-214-07 1 in 1 BOX
    2 113.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 04/19/2010
    Labeler - Kinray Inc. (012574513)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    Name Address ID/FEI Business Operations
    Galentic Pharma India Private Limited 918531450 manufacture(63777-214)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(63777-214)
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