Label: PETROLEUM- petrolatum jelly 

  • Label RSS
  • NDC Code(s): 51143-069-27, 51143-069-96
  • Packager: Onpoint, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    White petrolatum USP (100%)

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  • purpose

    Skin Protectant

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  • Uses

    • temporarily protects monor: 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
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  • Warnings

    For external use only

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  • When using this product

    • do not get into eyes
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  • Stop use and ask a doctor if

    condition lasts more than 7 days

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  • do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Keep out of reach of children

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

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  • Directions

    apply as needed

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  • Disclaimer

    This product is not manufactured or distributed by Unilever, distributor of Vaseline

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  • Adverse Reactions

    DISTRIBUTED BY ONPOINT, INC

    2 PARAGON DRIVE, MONTVALE, NJ 07645

    2013 ALL RIGHTS RESERVED

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  • principal display panel

    for BABY

    100% pure

    PETROLEUM JELLY

    skin protectant

    NET WT 13 OZ (368 g)

    COMPARE TO Vaseline

    image description

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  • INGREDIENTS AND APPEARANCE
    PETROLEUM 
    white petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51143-069
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51143-069-96 213 g in 1 JAR
    2 NDC:51143-069-27 368 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/14/2009
    Labeler - Onpoint, Inc (001367366)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(51143-069)
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