Label: FIRST AID ONLY STING RELIEF PAD- benzocaine, isopropyl alcohol liquid

  • 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 February 3, 2022

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  • Drug Facts


  • Active ingredients

    Benzocaine 6.0%

    Isopropyl Alcohol 60% w/v

    Purpose

    Topical Anesthetic

    Antiseptic

  • INDICATIONS & USAGE

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

    First aid to help prevent infection in minor cuts, scrapes, and burns.

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    Do Not Use

    • in eyes, if contact occurs flush with water ▪over large areas of the body

    Consult a doctor ▪if condition worsens ▪if symptoms last for more than seven days or clear up and occur again ▪for deep puncture wounds

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    ▪ For 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: consult physician

  • Inactive ingredient

    Purified Water

  • SPL UNCLASSIFIED SECTION

    Other information store at room temperature

  • PRINCIPAL DISPLAY PANEL

    Pouch labelpouch label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY STING RELIEF PAD 
    benzocaine, isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5204(NDC:59050-414)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL600 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5204-05100 in 1 BOX02/25/2022
    10.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0924-5204-0450 in 1 BOX02/25/2022
    20.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0924-5204-0325 in 1 BOX02/25/2022
    30.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:0924-5204-0210 in 1 BOX02/25/2022
    40.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    5NDC:0924-5204-010.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)02/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/25/2022
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5204) , repack(0924-5204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5204) , repack(0924-5204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595manufacture(0924-5204)
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