Label: STING RELIEF MEDICATED PAD- 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 January 24, 2019

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  • Active Ingredients

    Active ingredient

    Benzocaine 6%

  • Purpose

    Purpose

    Topical Anesthetic

  • Uses

    First relief of pain and itching associated with minor burns, scrapes and insect bites

  • WARNINGS

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

    Do not use

    • in the eyes
    • if contact occurs, flush eyes with water

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

  • 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

    • 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
  • Inactive ingredients

    isopropyl alcohol, purified water

  • Other Information

    Other Information

    Store at room temperature 15 o - 30 oC (59 o - 86 oF)

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    STING RELIEF MEDICATED PAD 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.06 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-004-011 in 1 PACKET; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/24/2019
    Labeler - Davemed Healthcare Co., Ltd (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-004)
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