Label: PETROLEUM SKIN PROTECTANT- petrolatum jelly

  • NDC Code(s): 37808-069-18, 37808-069-27, 37808-069-54
  • Packager: H E B
  • 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

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  • Active ingredient

    White petrolatum USP (100%)

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  • Purpose

    Skin protectant

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  • Uses

    • temporarily protects minor: cuts- scrapes- burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protects from the drying effectsw 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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  • See a doctor if

    condition lasts more than 7 days

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  • Do not use

    • 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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  • Dislcaimer

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

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  • Adverse Reactions

    DISTRIBUTED BY: H-E-B,

    SAN ANTONIO, TX 78204

    QUESTIONS? 1-888-593-0593

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  • Principal display Panel

    Compare to Vaseline

    NDC 37808-069-27

    Petroleum Jelly

    SKIN PROTECTANT

    Helps Protect Chapped Skin

    100% Pure

    NET WT 13 OZ (368 g)

    image description

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  • INGREDIENTS AND APPEARANCE
    PETROLEUM SKIN PROTECTANT 
    white petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-069
    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:37808-069-27 368 g in 1 JAR
    2 NDC:37808-069-54 106 g in 1 JAR
    3 NDC:37808-069-18 70.8 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/03/2009
    Labeler - H E B (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(37808-069)
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