Label: PETROLEUM- petrolatum jelly

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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  • Active Ingredient

    White Petrolatum (100%)

  • Purpose

    Skin protectant

  • Use

    • Helps treat and prevent diaper rash
    • Petroleum jelly restores smooth and healthy skin
    • Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind
    • For the temporary protection of minor cuts, scrapes, burns and sunburn
  • Warnings:

    For external use only

    Avoid contact with eyes.

  • Stop use and ask a doctor if

    condition worsens or does not improve after 7 days.

  • Keep out of reach of children

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

  • Directions

    Apply liberally, as often as necessary.

  • Inactive

    fragrance

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80801-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80801-104-01170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/01/2023
    Labeler - PRIMAL ELEMENTS (968334144)
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