Label: VITAMIN A AND D- petrolatum ointment

  • NDC Code(s): 57896-110-14
  • Packager: Geri-care Pharmaceutials Corp
  • 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 June 6, 2023

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  • Active Ingredient

    White Petrolatum 76%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects minor cuts, scrapes and burns.

    Temporarily protects and helps chapped lips and cracked skin

    Helps protect lips from drying effects of wind and cold weather

  • 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

    Do not get in 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

  • Distributed By

    Distributed By

    Geri-care Pharmaceuticals Corp

    1295 Towbin Avenue

    Lakewood, NJ 08701

  • Warnings

    For external use only

  • Questions

    Call: 1-800-540-3765

  • Other Information

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

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

    Avoid excessive heat and humidity

  • PRINCIPAL DISPLAY PANEL

    Geri Care Vitamin A and D-CDER

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-110
    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:57896-110-14144 in 1 CARTON01/13/2023
    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 finalpart34701/13/2023
    Labeler - Geri-care Pharmaceutials Corp (611196254)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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