Label: VITAMIN A AND D- petrolatum ointment

  • NDC Code(s): 69396-121-05
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 March 17, 2023

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  • Active Ingredient

    Petrolatum 76%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and relieves

    • minor cuts
    • scrapes
    • burns
    • chapped or cracked skin and lips
  • Stop use and ask a doctor

    Condition worsens

    Symptoms last more than 7 days or clear up and occur again with a few days

  • Keep out of reach of children

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

  • When using this product

    Avoid contact with eyes

  • Do Not Use

    • On deep or puncture wounds
    • Animal Bites
    • Serious Burns

  • Directions

    Apply as needed

  • Inactive ingredients

    mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Trifecta Pharmaceuticals USA

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301

    www.trifecta-pharma.com

    1-888-296-9067

  • Warnings

    For external use only

  • Questions

    Call: 1-888-296-9067

  • STORAGE AND HANDLING

    Store at room temperature 20º-25ºC (68º-77ºF)

    Tamper evident, do not use if packet is torn, cut or opened

    Avoid excessive heat and humidity

  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    Globe A and D Ointment 5g CDER

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-121
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-121-05144 in 1 CARTON10/14/2022
    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 finalpart34710/14/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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