Label: WHITE PETROLATUM- petrolatum ointment

  • NDC Code(s): 57896-114-05, 57896-114-14
  • Packager: GERI-CARE PHARMACEUTICAL 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 November 23, 2022

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  • Active Ingredient

    White Petrolatum 100%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor • cuts • scrapes • burns
    • Temporarily protects and helps chapped lips and cracked skin
    • Helps protect lips from drying effects of wind and cold weather

  • Warnings

    FOR EXTERNAL USE ONLY

  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    In case of deep puncture wounds or severe burns, consult a physician.

  • When using this product

    • do not get in eyes

  • 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.
  • 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.

  • Directions

    Apply as needed

  • Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-114-14144 in 1 CARTON05/01/2020
    1NDC:57896-114-055 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/202008/01/2024
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)
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