Label: FIRST AID ONLY STING RELIEF PAD- benzocaine swab

  • Category: HUMAN OTC DRUG LABEL

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 April 6, 2019

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  • Active Ingredients

    Benzocaine, 6% w/v

    Isopropyl Alcohol 60% w/v

  • Purpose

    Topical Anesthetic

    Antiseptic

  • INDICATIONS & USAGE

    Use

    For the temporary relief of pait and itching associated with minor burns, scrapes and insect bites. First aid to help prevent infection in minor cuts, scrapes, and burns

  • DOSAGE & ADMINISTRATION

    Directions

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

    ▪children under 2 years: consult a physician

  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from fire or flames

    Do not use

    • In the eyes. If contact occurs, rinse thoroughly with water
    • over large areas of the body

    Stop use

    If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

    Keep out of reach of children.

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water

  • STORAGE AND HANDLING

    Other Information

    Store at room temperature

  • Principal Display Panel - 0.4 mL Pouch Label

    0.4 mL Pouch Label 0.4 mL Pouch Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY STING RELIEF PAD 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5203(NDC:65517-0005)
    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 ALCOHOL0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5203-010.4 mL in 1 POUCH; Type 0: Not a Combination Product04/08/2019
    2NDC:0924-5203-0210 in 1 BOX04/08/2019
    20.4 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-5203-0325 in 1 BOX04/08/2019
    3NDC:0924-5203-010.4 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-5203-04100 in 1 BOX04/08/2019
    4NDC:0924-5203-010.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2019
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5203) , repack(0924-5203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5203) , repack(0924-5203)
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