Label: BURN WITH LIDOCAINE- benzalkonium chloride and lidocaine hydrochloride cream 

  • Label RSS
  • NDC Code(s): 47682-260-73, 47682-260-99
  • Packager: Unifirst First Aid Corporation
  • 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 01/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 2.0%

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  • Purpose

    First Aid Antiseptic

    External analgesic

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  • Uses

    First aid to help prevent infection and for the temporary relief of pain in

    • minor cuts
    • scrapes
    • burns
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  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
    • longer than 1 week, unless directed by a doctor
    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask doctor if

    • the condition gets worse
    • condition clears up and recurs within a few days
    • condition persists for more than 7 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

    Adults and children 2 years and older:

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage

    Children under 2 years

    • consult a doctor

    Other information

    • store at room temperature (do not freeze)
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

    aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

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  • Questions or comments?

    1-800-634-7680

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  • PRINCIPAL DISPLAY PANEL – box

    MEDI-FIRST

    BURN CREAM with Lidocaine

    Antiseptic and pain relieving cream
    for minor cuts, scrapes and burns

    0.9g (1/32oz) Packets

    25 per box

    PRINCIPAL DISPLAY PANEL – box
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  • PRINCIPAL DISPLAY PANEL – packet

    First Aid Burn Cream
    with Lidocaine

    1/32oz.

    ANTISEPTIC AND PAIN RELIEVING CREAM

    (0.9g)

    Manufactured for Medique Products, Fort Myers, FL 33967 USA

    PRINCIPAL DISPLAY PANEL – packet
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  • INGREDIENTS AND APPEARANCE
    BURN WITH LIDOCAINE 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:47682-260
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 1.3 mg  in 1 g
    Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 5.0 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    alcohol  
    methylparaben  
    mineral oil  
    paraffin  
    petrolatum  
    propylparaben  
    water  
    white wax  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-260-73 25 in 1 BOX
    1 NDC:47682-260-99 0.9 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/24/2012
    Labeler - Unifirst First Aid Corporation (832947092)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(47682-260)
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