Label: A AND D PLUS E- vitamin a, d, and e ointment 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 November 6, 2020

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  • ACTIVE INGREDIENT

    Petrolatum 99.85%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    temporarily protects minor:

    • cuts
    • scrapes
    • burns

    temporarily protects and helps relieve chapped, chafed, or cracked skin and lips

    helps protect from the drying effects of wind and cold weather

  • WARNINGS

    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 within a few days

    Do not use on

    • deep 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.

    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 within a few days

    Stop use and ask a doctor if

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

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

    For external use only

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    • apply as needed

    apply as needed

  • STORAGE AND HANDLING

    Other information

    store between 20ºC to 25ºC (68ºF to 77ºF)

    avoid direct sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients

    medium chain triglyceride oil, vitamin A palmitate, vitamin D 3, vitamin E (alpha-tocopherol)

  • QUESTIONS

    Questions?

    Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

  • PRINCIPAL DISPLAY PANEL

    Gentell We make it better

    GEN-23450

    A&D+E Ointment

    Skin Protectant

    13 oz. (369 g)

    Gentell 2701 Bartram Road, Bristol, PA 19007 www.gentell.com

    Front Panel

  • INGREDIENTS AND APPEARANCE
    A AND D PLUS E 
    vitamin a, d, and e ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.9985 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61554-200-0156.7 g in 1 TUBE; Type 0: Not a Combination Product11/03/2014
    2NDC:61554-200-02113.4 g in 1 TUBE; Type 0: Not a Combination Product11/03/2014
    3NDC:61554-200-03368.5 g in 1 JAR; Type 0: Not a Combination Product11/03/2014
    4NDC:61554-200-04453.6 g in 1 JAR; Type 0: Not a Combination Product11/03/2014
    5NDC:61554-200-05567 g in 1 JAR; Type 0: Not a Combination Product11/03/2014
    6NDC:61554-200-065 g in 1 PACKET; Type 0: Not a Combination Product11/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/03/2014
    Labeler - Gentell, Inc. (170967876)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gentell, Inc.170967876manufacture(61554-200)