Label: AG INTERNATIONAL VITAMIN A AND D- white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL

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 23, 2019

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  • Active Ingredient

    White Petrolatum USP (76% 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, espicially 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

    ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

  • Do not use on

    ■ animal bites ■ deep or puncture wounds ■ serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

  • Other Information

    ■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

  • Inactive ingredients

    lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

  • Package Label

    Drug fact Panel

  • INGREDIENTS AND APPEARANCE
    AG INTERNATIONAL  VITAMIN A AND D
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73235-3045
    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
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73235-3045-25 g in 1 PACKET; Type 0: Not a Combination Product07/23/2019
    2NDC:73235-3045-328.3 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
    3NDC:73235-3045-4113 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
    4NDC:73235-3045-5425 g in 1 JAR; Type 0: Not a Combination Product07/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/23/2019
    Labeler - AG International (675480459)
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