Label: ALLURE CREAMY PETROLEUM- petrolatum jelly

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 19, 2012

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  • Allure Creamy Petroleum Jelly


  • Active Ingredient

    Petrolatum 30%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • 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 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 Ingredients

    Aqua, Carbomer, Stearic Acid, Glyceryl Monostearate, Paraffinum Liquidum, Cetearyl Alcohol, Methylparaben, Propylparaben, Triethanolamine, Tocopheryl Acetate, Parfum

  • Distributed By:

    Universal Distribution Center
    96 Distribution BLVD.
    Edison, NJ 08817
    Made in China
  • Allure Creamy Petroleum Jelly 7oz (52000-000-00)

    PetroleumJelly

  • INGREDIENTS AND APPEARANCE
    ALLURE CREAMY PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-000-00200 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/19/2012
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd.528196956manufacture(52000-000)
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