Label: MEDICAINE STING AND BITE- benzocaine swab

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 17, 2020

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  • Drug Facts

  • Active ingredient

    Benzocaine (20%), L-Methol (1%)

  • PURPOSE

    analgesic

  • Uses

    For temporary relief of pain and itching associated with insect bites and stings

  • Warning

    Do not use in the eyes

    Not for prolonged use

  • Stop use

    If condition for this preparatiob is used persists or if a rash or irritation develops

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away

  • Directions

    reverse cardboard sleeve then crish at dot between thumb and forefinger. Once solution has saturated tip, apply to sting or bite.

  • Other Safety Information

    Store at room temperature away from light

  • Inactive Ingredients

    D&C Green Dye #5 D&C Yellow Dye #10, FD&C Blue Dye #1, PEG 300 NF, Isopropyl Alcohol, Purified Water, USP

  • PRINCIPAL DISPLAY PANEL

    u1-19.jpg

  • INGREDIENTS AND APPEARANCE
    MEDICAINE STING AND BITE 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.12 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68183-118-0110 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2015
    Labeler - Custom Kits Company Inc (928643712)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(68183-118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Kits Company Inc928643712relabel(68183-118) , repack(68183-118)