Label: MEDLIFE A AND D- 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 November 5, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients (In Each Gram): White Petrolatum 93.5%

  • PURPOSE

    skin protectant

  • INDICATIONS & USAGE

    Uses:

    Temporarily protects and relieves:

    • minor cuts • scrapes • burns

    • chapped or cracked skin and lips

    • helps protect lips from drying effects of wind and cold weather

  • WARNINGS

    Warnings:

    • For external use only

  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens

    • symptoms last for more than 7 days or clear up and occur again within a few days

    When using this product:

    • avoid contact with eyes

  • DO NOT USE

    Do not use:

    • deep or puncture wounds

    • animal bites

    • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • apply as needed

  • OTHER SAFETY INFORMATION

    Other Information:

    • Tamper Evident. Do not use if packet is torn, cut or opened.

    • Store at a controlled room temperature 15° to 30°C (59° to 86°F).

    • Avoid excessive heat and humidity.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    corn oil, light mineral oil, vitamin A palmitate and vitamin D

  • PRINCIPAL DISPLAY PANEL

    MedLife A&D Ointment

  • INGREDIENTS AND APPEARANCE
    MEDLIFE A AND D 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73285-375
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM935 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A (UNII: 81G40H8B0T)  
    ERGOCALCIFEROL (UNII: VS041H42XC)  
    CORN OIL (UNII: 8470G57WFM)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73285-375-47144 in 1 CARTON12/01/2019
    1NDC:73285-375-055 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2019
    Labeler - Qualmax Supplies Inc. (013132887)
    Registrant - Qualmax Supplies Inc. (013132887)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(73285-375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gandhar Oil Refinery (india)limited725188184manufacture(73285-375)
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