PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]

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PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]
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NDC 50346-001-01, 50346-001-02, 50346-001-03, 50346-001-04, 50346-001-05, 50346-001-06, 50346-001-07, 50346-001-08, 50346-001-09
Set ID eeaebd3b-2b23-4bf1-b130-93e1cf4591cc
Category HUMAN OTC DRUG LABEL
Packager Pan Aromas LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    White petrolatum USP (100 %)

  • Purpose

    Skin protectant

  • Uses

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

    if condition worsens or does not improve after 7 days.

  • Keep out of reach of children

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

  • Directions

    Apply liberally, as often as necessary.

  • Inactive ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    PURE PETROLEUM JELLY
    NET WT. 8 OZ (226 g)

    PRINCIPAL DISPLAY PANEL



  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50346-001-01100 g in 1 JAR
    2NDC:50346-001-02113 g in 1 JAR
    3NDC:50346-001-03142 g in 1 JAR
    4NDC:50346-001-04170 g in 1 JAR
    5NDC:50346-001-05198 g in 1 JAR
    6NDC:50346-001-06226 g in 1 JAR
    7NDC:50346-001-07255 g in 1 JAR
    8NDC:50346-001-08283 g in 1 JAR
    9NDC:50346-001-09368 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/26/2012
    Labeler - Pan Aromas LLC (078451131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture
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