Label: SOFTLIPS TROPICAL COCONUT- dimethicone stick

  • NDC Code(s): 10742-7007-1
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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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 finalpart34709/30/2019
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-7007)
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