Label: BURN- lidocaine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 2%

  • Purpose

    Topical pain reliever

  • Uses

    For the temporary relief of pain associated with minor burns.

  • Warnings

    For external use only.

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if condition worsens or persist for more then 7 days or clears up and returns.

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

  • Directions

    • 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 a doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    Aloe vera, germaben II, propylene glycol, purified water

  • Questions?

    1-866-651-3660

    Mon-Fri 8:00am-5:00pm EST

    Manufactured for American Safety & First Aid Osceola, IN 46561

    V1_11-7-19

  • Principal Display Panel – Bottle Label

    0671

    NDC 73598-0671-1

    Burn Spray

    Topical Pain Relief

    For Temporary Pain
    Relief of Minor Burns.

    American Safety
    & First Aid

    2 fl. Oz. (59.1 ml)

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-0671
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-0671-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/14/2020
    Labeler - JHK Inc (867236309)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(73598-0671)
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