PURE PETROLEUM (PETROLATUM) JELLY [SHIELD LINE LLC]

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PURE PETROLEUM (PETROLATUM) JELLY [SHIELD LINE LLC]
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NDC 52410-0202-2, 52410-0202-4
Set ID 35c163e6-ae58-2791-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Shield Line 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, scrapes, burns and sunburn
    • helps to temporarily protect chafed , chapped , cracked or windburned skin and lips
  • Warnings: FOR EXTERNAL USE ONLY

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

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

    • condition worsens
    • symptoms last more than 7 days or clean up and occur again in a few days
  • Keep out of reach of childen

    • if swalloed , get medical help or contact a Proison Control Center right away
  • Directions

    • apply as needed
  • Other Information

    • Store at room temperature
  • Inactive Ingradients

    None

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-0202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-0202-2226 g in 1 JAR; Type 0: Not a Combination Product06/21/2016
    2NDC:52410-0202-4368 g in 1 JAR; Type 0: Not a Combination Product06/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/21/2016
    Labeler - Shield Line LLC (078518916)
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