VITAMIN A D (PETROLATUM) OINTMENT [DYNAREX CORPORATION]

VITAMIN A D (PETROLATUM) OINTMENT [DYNAREX CORPORATION]
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NDC 67777-215-01
Set ID 4711232c-31a8-4a2c-b2a3-cb53030c4bc0
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    White Petrolatum USP 93% w/w

  • Purpose

    Skin Protectant

  • 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 into eyes

  • Stop use and ask a doctor if:

    • The condition persists or gets worse
    • Symptoms last more than 7 days or clear up and occur again in a few days
  • Do not use on:

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

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

    • Store at room temperature 15°-30°C (59° - 86°F)
    • Avoid excessive heat and humidity
    • Tamper Evident. Do not use if packet is torn, cut or opened
  • Inactive Ingredients

    Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

  • Principal Display Panel

    NDC 67777-215-01

    Vitamins A & D Ointment

    Diaper Rash Ointment

    Skin Protectant

    144 Packets

    Net Wt 5 grams

    Label

  • INGREDIENTS AND APPEARANCE
    VITAMIN A D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.93 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-215-015 g in 1 PACKET; Type 0: Not a Combination Product10/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2013
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Mexico SAPI de CV951575186manufacture(67777-215)