Label: PETROLEUM- white petrolatum jelly

  • 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 April 26, 2022

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  • Active ingredient

    White petrolatum USP 99.8%

    Purpose

    Skin protectant

  • Use

    • temporarily protects minor: •cuts •scrapes •burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product

    • do not get into eyes.

    Do not use

    • deep or puncture wounds
    • animal bite
    • serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms longer than 7 days or clear up and occur again with in a few days

    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

    aloe barbadensis leaf extract, fragrance, tocopherol (vitamin E)

  • principal display panel

    Since 1903

    Rexall

    Petroleum Jelly

    Skin Protectant with Vitamin E and Aloe

    • Temporarily protects minor cuts, scrapes and burns
    • Temporarily protects and helps relieve chapped or cracked skin and lips

    NET WT 13 OZ (368 g)

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM838 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-235-27368 g in 1 JAR; Type 0: Not a Combination Product01/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/26/2011
    Labeler - OLD EAST MAIN CO. (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-235)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-235)