UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED (WHITE PETROLEUM) JELLY [UNIVERSAL DISTRIBUTION CENTER LLC]

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UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED (WHITE PETROLEUM) JELLY [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-007-19, 52000-007-20, 52000-007-21, 52000-007-22, 52000-007-23, 52000-007-24, 52000-007-25, 52000-007-26, 52000-007-27, 52000-007-28
Set ID 649e571f-0cd6-41e4-b31f-c818f94fb01d
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (100 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • 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.
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product as liberally, as often as necessary.

  • INACTIVE INGREDIENT

    Inactive ingredients

    None

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED JELLY
    SKIN PROTECTANT
    NET WT. 13 OZ (368 g)

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0001 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-007-19226 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    2NDC:52000-007-2045 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    3NDC:52000-007-21100 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    4NDC:52000-007-22113 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    5NDC:52000-007-23170 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    6NDC:52000-007-24198 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    7NDC:52000-007-25283 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    8NDC:52000-007-26368 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    9NDC:52000-007-27450 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    10NDC:52000-007-28500 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/06/2013
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-007)
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