Label: DYVE COMFORT L- menthol, lidocaine gel

  • 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 March 20, 2018

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  • Active Ingredients

    Lidocaine 4%

    Menthol 1%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    On large areas of the body or on cut, irritated or swollen skin
    On puncture wounds
    For more than one week without consulting a doctor

    When using this product:

    Use only as directed

    Read and follow all direction and warnings on this carton

    Do not allow contact with eyes

    Do not bandage or apply local heat to the area of use

    Stop using and ask a doctor if

    Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding,

    ask a health professional before use

    Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

  • Other information

    Store at 20-25ºC (68-77ºF)

  • Inactive ingredients

    benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water

  • Questions?

    1-833-DYVE-BIO

  • PRINCIPAL DISPLAY PANEL

    Dyve Comfort L box

  • INGREDIENTS AND APPEARANCE
    DYVE COMFORT L 
    menthol, lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70458-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70458-103-201 in 1 BOX04/01/2018
    1200 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2018
    Labeler - AmperSand Biopharmaceuticals (080111681)
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