Label: FIRST AID ONLY STING RELIEF PAD- benzocaine patch

  • 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 July 31, 2017

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  • Active Ingredients

    Active Ingredients Benzocaine, 6%

  • Purpose

    Topical Analgesic

  • Use

    Use For temporary relief of pain and itching associated with minor burns, scapes and insect bites

  • Warnings

    Warnings •for external use only •flammable, keep away from fire or flame

  • Do Not Use

    Do Not Use •in the eyes •if contact occurs, flush eyes with water

  • Keep out of reach of children

    Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away

  • Directions

    Directions •apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older

    •Children under 2 years: consult physician

  • Other Information

    Other Information Store at room temperature 15° - 30°C (59° - 86°F)

  • Inactive Ingredients

    Inactive Ingredients isopropyl alcohol, purified water

  • Package Principal Display Panel

    Label Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY STING RELIEF PAD 
    benzocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5201(NDC:44019-520)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5201-011 in 1 POUCH07/31/2017
    10.42 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2017
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5201) , repack(0924-5201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5201) , repack(0924-5201)