Label: VITAMIN A D- petrolatum ointment

  • NDC Code(s): 67777-215-07, 67777-215-08
  • Packager: Dynarex Corporation
  • 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 December 13, 2022

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  • Active Ingredient

    White Petrolatum, USP, 93% w/w

  • Purpose

    Skin Protectant

  • Use(s)

    • Helps treat chafed skin associated with diaper rash

    • Helps seal out wetness

    • Temporarily protects minor • Cuts • Scrapes • Burns

    • Temporarily helps protext and relieve chapped and cracked skin and lips

    • Helps prevent and protect from the drying effects of wind and cold weather

  • 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

    • Apply as needed

    • Change wet and soiled diapers promptly

    • Cleanse the diaper area and allow to dry

    • Apply ointment liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet

    diapers may be prolonged.

  • Other Information

    • Store at room temperature 15º-30ºC (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

  • Label

    1150 BX MASTER1150 Vitamin A&D Ointment

  • 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) PETROLATUM93 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-215-08864 in 1 CASE03/28/2022
    1NDC:67777-215-07144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/28/2022
    Labeler - Dynarex Corporation (008124539)
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