Label: SOFTLIPS TROPICAL COCONUT- dimethicone stick

  • NDC Code(s): 10742-7007-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredients

    Dimethicone 2%

  • Purpose

    Dimethicone - Skin protectant

  • Uses

    • helps prevent and temporarily protects chapped or cracked lips
    • 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 within a few days
  • 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

    ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetatate [vitamin E]

  • Questions?

    1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

  • Package/Label Principal Display Panel

    Softlips Coconut
  • Package/Label Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS  TROPICAL COCONUT
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-7007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SQUALANE (UNII: GW89575KF9)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-7007-11 in 1 BLISTER PACK09/30/2019
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/2019
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-7007)
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