Label: VITAMINS A AND 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 November 10, 2021

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  • Drug Facts

  • 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 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 wetness may be prolonged
  • Warnings:

    For external use only

    When using this product

    • Do not get into eyes

    Stop Use and consult a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and reoccur in a few days

    Do not use on

    • deep punture wounds
    • animal bites 
    • serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions for use with Diaper Rash

    • change wet and soiled diaper promptly
    • cleanse the diaper area and allow to dry
    • apply as needed
  • Other information

    • store at 15°-30°C (59°-86°F)
    • avoid excessive heat and humidity
  • Inactive Ingredients

    Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A and Vitamin D

  • Package Labeling:

    InnerLabel

  • INGREDIENTS AND APPEARANCE
    VITAMINS A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM930 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-009-00144 in 1 BOX03/16/2020
    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 finalpart34703/16/2020
    Labeler - Geri-Gentle Corporation (080367686)
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