Label: INSECT STING RELIEF- benzocaine, alcohol cloth

  • NDC Code(s): 83165-003-00
  • Packager: Hubei Fanjian Medical Product Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • Active ingredients

    Benzocaine, 6% w/v

    SD alcohol, 60% w/v

    Purpose

    Topical Anesthetic`

    Antiseptic

  • Use:

    For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

  • Warnings:

    For external use only.

    Do not use:

    In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other'symptoms occur, consult a physician immediately.

    Keep out of reach of children.

    If swallowed, get medical Thelp or contact a Poison Control Center right away.Flammable - keep away from fire or flame. Avoid contact with eyes.  If this happens, rinse thoroughly with water.

  • Directions:

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a  doctor.

  • Inactive ingredients

    Purified water.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    INSECT STING RELIEF 
    benzocaine, alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83165-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83165-003-000.62 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/14/2023
    Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Fanjian Medical Product Co.,Ltd846385590manufacture(83165-003)