Label: UNIVERSAL BABY FRESH SCENT PETROLEUM- petrolatum jelly

  • NDC Code(s): 52000-006-19, 52000-006-20, 52000-006-21, 52000-006-22, view more
    52000-006-23, 52000-006-24, 52000-006-25, 52000-006-26, 52000-006-27, 52000-006-28
  • Packager: Universal Distribution Center LLC
  • 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 02/13

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  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (99.9 %)

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  • PURPOSE

    Purpose

    Skin Protectant

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  • INDICATIONS & USAGE

    Uses

    • For the temporary protection of minor cuts, scrapes, burns and sunburn.
    • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.
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  • WARNINGS

    Warnings

    For External Use Only.

    Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask doctor if condition worsens or does not improve within 7 days.

    Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply product as liberally, as often as necessary.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    None

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  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    UNIVERSAL BABY FRESH SCENT PETROLEUM
    SKIN PROTECTANT
    NET WT. 13 OZ (368 g)

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  • INGREDIENTS AND APPEARANCE
    UNIVERSAL BABY FRESH SCENT PETROLEUM 
    white petroleum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52000-006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 0.99 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52000-006-19 226 g in 1 JAR
    2 NDC:52000-006-20 45 g in 1 JAR
    3 NDC:52000-006-21 100 g in 1 JAR
    4 NDC:52000-006-22 113 g in 1 JAR
    5 NDC:52000-006-23 170 g in 1 JAR
    6 NDC:52000-006-24 198 g in 1 JAR
    7 NDC:52000-006-25 283 g in 1 JAR
    8 NDC:52000-006-26 368 g in 1 JAR
    9 NDC:52000-006-27 450 g in 1 JAR
    10 NDC:52000-006-28 500 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 02/06/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52000-006)
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