Label: LUCKY SUPER SOFT COCOA BUTTER- white petrolatum cream

  • Category: HUMAN OTC DRUG LABEL

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 July 9, 2021

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  • Active ingredient

    White petrolatum USP (30%)

  • Purpose

    Skin protectant

  • Uses

    ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and 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 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 ingredients

    water, cetearyl alcohol, ceteareth 20, glycerin, mineral oil, fragrance, benzyl alcohol, methylchloroisothaizolinone, methylisothaizolinone, titanium dioxide, citric acid, tocopheryl acetate, theobroma cacao seed butter, FDC yellow no 6, DC red no 33, FDC yellow no 5, FDC blue no 1

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT  COCOA BUTTER
    white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-121
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-121-45127 g in 1 TUBE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2015
    Labeler - Delta Brands Inc (102672008)