ROYAL PETROLEUM JELLY (PETROLATUM) JELLY [ROYAL EXPORTS]

ROYAL PETROLEUM JELLY (PETROLATUM) JELLY [ROYAL EXPORTS]
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NDC 51328-1010-3, 51328-1010-4, 51328-1010-5
Set ID 3ec6154f-d2e4-48bf-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Royal Exports
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    White petrolatum (100 % 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 the drying effects of wind and cold weather
    • helps treat and prevent diaper rash
    • helps seal out wetness
  • Warnings

    FOR EXTERNAL USE ONLY

  • 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 clear up and occur again within 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

    None

  • PRINCIPAL DISPLAY PANEL

    Package Labelprincipal Display Label

  • INGREDIENTS AND APPEARANCE
    ROYAL PETROLEUM JELLY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51328-1010
    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:51328-1010-3226 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    2NDC:51328-1010-5368 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    3NDC:51328-1010-4283 g in 1 JAR; Type 0: Not a Combination Product10/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2016
    Labeler - Royal Exports (650621381)

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