Label: STING RELIEF PAD- benzocaine, isopropyl alcohol swab

  • 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 May 9, 2018

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  • Drug Facts

  • Active Ingredients

    Benzocaine, 6%

    Isopropyl alcohol 60% w/v

    Purpose

    Topical Analgesic

    Antiseptic

  • Use

    For the temporary relief of pain and itching associated with minor burns, 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

    Keep out of the 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 or older, apply to affected area not more than 3 to 4 times daily
    • Children under 2 years: consult ohysician
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    purified water

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    STING RELIEF PAD 
    benzocaine, isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5202(NDC:59050-059)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 g
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL600 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5202-010.34 g in 1 POUCH; Type 0: Not a Combination Product05/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/09/2018
    Labeler - Acme United Corporation (001180207)
    Registrant - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5202) , repack(0924-5202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599repack(0924-5202) , relabel(0924-5202)