Label: MEDICAINE STING AND BITE- benzocaine swab

  • NDC Code(s): 46414-2040-3
  • Packager: James Alexander Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 31, 2019

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  • Drug Facts

  • Active Ingredients (each swab)

    Benzocaine USP (20%), L-Menthol USP (1%)

  • Purpose

    analgesic

  • Uses

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

  • Warnings

    For external use only

    • do not use in the eyes or mouth
    • not for prolonged use
    • do not apply other medications to the same affected areas unless advised by a doctor

    Stop use and ask a doctor if condition for this preparation is used persists, or if a rash or irritation or allergic reaction develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Not for use with children less than 2 years old without medical advice. If swallowed, get medical help immediately or contact a Poison Control Center right away.

  • Directions

    Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bite. May be used on affected area(s) up to 4 times per day.

  • Other 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 USP, Purified Water USP.

  • Questions?

    Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t

  • SPL UNCLASSIFIED SECTION

    DISPENSING SOLUTIONS®

    JAMES ALEXANDER CORPORATION

    Blairstown, NJ. (908) 362-9266

    Product information and MSDS available on-line at:

    www.james-alexander.com

    Void of Aqueous

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MEDICAINE STING AND BITE 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-2040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) BENZOCAINE0.12 g  in 0.6 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.006 g  in 0.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46414-2040-36 mL in 1 CARTON; Type 0: Not a Combination Product11/15/1986
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/1986
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(46414-2040)
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