Label: BENZOCAINE swab

  • 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 March 22, 2011

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  • Active Ingredient

    Active Ingredient                             Purpose                  

    Benzocaine, 6% w/v                       Topical Analgesic

    Isopropyl Alcohol, 70% w/v              Antiseptic

  • Purpose

    • For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
  • Keep Out of Reach of Children

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center.
  • Indications and Usage

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

    Warnings:

    • For external use only.
    • Flammable, keep away from fire or flame.

  • Dosage

    Directions:

    • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
    • Children under 2 years; consult a physician.






  • Inactive Ingredients

    • Inactive Ingredient: Water.
  • Do Not Use

    Do not use: 

    • With electrocautery procedures.
    • In the eyes.

  • Stop Use

    Stop use:

    • If irritation and redness develop.
    • If condition persists for more than 72 hours, consult a physician.

  • Storage and Handling

    • Avoid excessive heat.
    • Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)
  • Principal Display

    Sting and Bite Pad

    Benzocaine




  • INGREDIENTS AND APPEARANCE
    BENZOCAINE 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.12 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-235-013000 in 1 CASE
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/24/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Kanglin Health Protection Products Co Ltd530576131manufacture
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