Label: LIDOCAINE HYDROCHLORIDE liquid

  • NDC Code(s): 61010-5100-4, 61010-5100-5
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water

    Stop use and ask a doctorif condition worsens or persists for more than 7 days or clears up and returns

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

    • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
    • for children under 2 years of age consult a physician
  • Inactive ingredients

    aloe vera, germaben II, propylene glycol, purified water

    Manufactured by SAFETEC OF AMERICA, Inc.

    Buffalo, NY 14215 800-456-7077 www.safetec.com

    PAIN RELIEF – Burn Spray 
    Safetec of America

    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.
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  • PRINCIPAL DISPLAY PANEL – 3 oz. bottle

    NDC 61010-5100-3

    Safetec

    First Aid
    Burn Spray

    For Temporary
    Pain Relief of
    Minor Burns

    3 fl. oz. (88.7 ml)

    Reorder no. 50104

    PRINCIPAL DISPLAY PANEL – 3 oz. bottle
  • PRINCIPAL DISPLAY PANEL – 2 oz. bottle

    NDC 61010-5100-4

    Safetec

    First Aid
    Burn Spray

    For Temporary
    Pain Relief of
    Minor Burns

    2 fl. oz. (59.1 ml)

    Reorder no. 50004

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle
  • PRINCIPAL DISPLAY PANEL – 4 oz. bottle

    NDC 61010-5100-5

    Safetec

    First Aid
    Burn Spray

    For Temporary
    Pain Relief of
    Minor Burns

    4 fl. oz. (118 ml)

    Reorder no. 50005

    PRINCIPAL DISPLAY PANEL – 4 oz. bottle
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5100
    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:61010-5100-459.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/02/2011
    2NDC:61010-5100-5118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/02/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/02/2011
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5100)
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