Label: VITAMINS A AND D- white petroleum 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 July 21, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient:
    White Petroleum USP (76%w/w)

  • PURPOSE

    Purpose:
    Skin Protectant

  • WARNINGS

    Warnings:
    For external use only

  • STOP USE

    Stop use and ask a doctor 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 the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions for Diaper Rash:

    • Change wet and soiled diapers promptly.
    • Cleanse the diaper area and allow to dry.
    • Apply as needed.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Mineral oil, Vitamin A, Vitamin D

  • OTHER SAFETY INFORMATION

    Other Information:

    • Store at room temperature 59-86 F(15-30C)
    • Avoid excessive heat.
  • INDICATIONS & USAGE

    Uses:

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor cuts, scrapes, burns
    • Temporarily helps protect and relieve chapped and cracked skin or 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
  • WHEN USING

    When using this product, do not get into eyes.

  • DO NOT USE

    Do not use on

    • deep puncture wounds
    • animals bites
    • serious burns

  • PRINCIPAL DISPLAY PANEL

    image of tube label

  • INGREDIENTS AND APPEARANCE
    VITAMINS A AND D 
    white petroleum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72464-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72464-001-01113 g in 1 TUBE; Type 0: Not a Combination Product07/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/22/2018
    Labeler - Tri-state Surgical Supply & Equipment Ltd. (040799991)
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