Label: VITAMIN A D- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 3, 2022

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  • 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) PETROLATUM0.93 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)