Label: AGVIT AD- white 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 July 23, 2019

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  • Active Ingredient

    White petrolatum USP (76% w/w)

  • Purpose

    Skin Protection

  • 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

    ■ 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

    For Skin Protection and Diaper rash ■ apply as needed

    Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

  • Other Information

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

  • Inactive ingredients

    lanolin, vitamin A palmitate , vitamin D3 in corn oil, quaternium-15

  • Package Label

    Principal Display

  • INGREDIENTS AND APPEARANCE
    AGVIT AD 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73235-8036
    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)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73235-8036-2100 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
    2NDC:73235-8036-3425 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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