Label: LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride gel 

  • Label RSS
  • NDC Code(s): 61010-5000-0, 61010-5000-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Pain Relief

    Drug Facts

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  • Active Ingredient

    Lidocaine HCl 2.0%

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  • Purpose

    Topical pain relief

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  • Uses

    Temporary pain relief for minor burns

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  • 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 doctor if condition worsens or persists for more than 7 days or clears up and occurs again within a few days

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away

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  • Directions

    • for adults and children 2 years and older: apply to affected area not more than 4 times daily
    • children under 2: do not use, consult a doctor
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  • Inactive ingredients

    aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

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  • PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

    NDC 61010-5000-0

    Safetec

    Burn Gel

    For Temporary
    Pain Relief of
    Minor Burns

    0.125 oz. (3.7 ml)
    Reorder no. 50000

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215
    800-456-7077
    www.safetec.com

    PRINCIPAL DISPLAY PANEL – 0.125 oz. packet
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  • PRINCIPAL DISPLAY PANEL – 4 oz. bottle

    NDC 61010-5000-4

    Safetec

    First Aid
    Burn Gel

    For Temporary
    Pain Relief of
    Minor Burns

    4 fl. oz. (118 ml)
    Reorder no. 50001

    PRINCIPAL DISPLAY PANEL – 4 oz. bottle
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  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61010-5000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    propylene glycol  
    diazolidinyl urea  
    water  
    menthol  
    .alpha.-tocopherol acetate  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61010-5000-0 3.3 g in 1 PACKET
    2 NDC:61010-5000-1 121.2 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/19/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(61010-5000)
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