Label: XTRACARE CREAMY PETROLEUM JELLY VITAMIN E ENRICHED- petrolatum cream

  • 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 September 12, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

    Petrolatum 30% ........................ Skin Protectant

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    XtraCare® Creamy Petroleum Jelly

    Vitamin E enriched

    Skin Softener

    Dry Skin Relief Absorbs Quickly Fragrance Free

    *Compare to the active ingredient in Vaseline® Petroleum Jelly Cream

    Net Wt 7oz (198g)

    XtraCare®

    XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Vitamin E to product a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

  • WARNINGS

    Warnings

    For external use only

    When using this productdo 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

  • DOSAGE & ADMINISTRATION

    Directionsapply as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients: water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, ethylene brassylate, tocopheryl acetate

  • OTHER SAFETY INFORMATION

    Other informationStore at room temperature.

    Questions/Comments?  1-855-345-5575

    *This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline ®

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE CREAMY PETROLEUM JELLY  VITAMIN E ENRICHED
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59 g  in 198 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-040-01198 g in 1 PACKAGE; Type 0: Not a Combination Product01/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/24/2014
    Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-040)
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