Label: FIRST AID AND BURN- benzalkonium chloride and lidocaine hydrochloride cream 

  • Label RSS
  • NDC Code(s): 0924-5701-01, 0924-5701-04, 0924-5701-09
  • Packager: Acme United 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

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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 itching associated with

    • minor cuts
    • scrapes
    • burns
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  • Warnings

    For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor
    • in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens or persists for more than 7 days
    • 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

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product to the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
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  • Other information

    • store at room temperature
    • do not use if packet is opened or torn
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  • Inactive ingredients

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

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  • Questions? 1-800-835-2263

    REORDER
    www.PhysiciansCareFirstAid.com
    1 800 835 2263

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  • PRINCIPAL DISPLAY PANEL – 0.9 gram packet

    NDC 0924-5701-01

    PhysiciansCARE

    Burn Cream

    0.9 g (1/32 oz.)

    Acme United Corporation

    Fairfield, CT 06824 800-835-2263

    PRINCIPAL DISPLAY PANEL – 0.9 gram packet
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  • PRINCIPAL DISPLAY PANEL – 10 count box

    PhysiciansCARE

    Burn Cream

    Benzalkonium chloride First aid antiseptic
    Lidocaine HCl External Analgesic

    10 Single use Packets 0.9 g each

    Reorder No. 51014

    ANSI Z308.1

    PRINCIPAL DISPLAY PANEL – 10 count box
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  • INGREDIENTS AND APPEARANCE
    FIRST AID AND BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0924-5701
    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 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    alcohol  
    methylparaben  
    mineral oil  
    paraffin  
    propylparaben  
    water  
    petrolatum  
    white wax  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0924-5701-04 10 in 1 BOX
    1 NDC:0924-5701-01 0.9 g in 1 PACKET
    2 NDC:0924-5701-09 10 in 1 BOX
    2 NDC:0924-5701-01 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 part333A 01/27/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(0924-5701)
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