Label: BURN- lidocaine hydrochloride spray

  • 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 14, 2020

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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 not finalpart34802/14/2020
    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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