Label: WHITE PETROLATUM- petrolatum ointment

  • NDC Code(s): 57896-164-14
  • Packager: Geri-Care Pharmaceuticals, 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 February 6, 2023

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  • Active Ingredient

    White Petrolatum 100%

  • Purpose

    Skin Protectant

  • 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.

  • 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 right away.

  • When using this product

    Avoid contact with eyes

  • Inactive Ingredients:

    None

  • Do Not Use

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

  • Directions

    Apply as needed

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Geri-Care Pharmaceuticals Corp.

    1295 Towbin Avenue

    Lakewood, NJ. 08701

    1-800-540-3765

  • Warnings

    For external use only

  • Questions

    Call: 1-800-540-3765

  • STORAGE AND HANDLING

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

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

    Avoid excessive heat and humidity

  • Package Label

    Geri care White petrolatum 5g Rev1122 CDER

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-164-14144 in 1 CARTON01/06/2023
    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 finalpart34701/06/2023
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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