NOVITA BABY PETROLATUM JELLY (PETROLATUM) JELLY [SHIELD LINE LLC]

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NOVITA BABY PETROLATUM JELLY (PETROLATUM) JELLY [SHIELD LINE LLC]
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NDC 52410-1021-3, 52410-1021-5
Set ID 3e9cf8bf-929b-45bf-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 (99.9% w/w)

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor cuts, scrapes, burns and sunburn
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from drying effect of wind and cold weather
    • helps treat and prevent diaper rash
    • help seal out wetness
  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

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

    • condition worsens
    • symptoms last for more than 7 days or clean up and occur again in a few days
  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • apply as needed
  • Inactive Ingredient

    Fragrance

  • Package Label

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    NOVITA BABY PETROLATUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-1021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-1021-3226 g in 1 JAR; Type 0: Not a Combination Product10/11/2016
    2NDC:52410-1021-5368 g in 1 JAR; Type 0: Not a Combination Product10/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/11/2016
    Labeler - Shield Line LLC (078518916)
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