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

  • Category: HUMAN OTC DRUG LABEL

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 May 24, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid Antiseptic

    Topical analgesic

  • Uses

    • for the temporary relief of pain associated with minor burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only

    Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center right away.

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
    • for more than one week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Directions

    Adults and children 2 years and over: clean affected area, apply small amount not more than 3 to 4 times daily

    Children under 2 years: do not use, consult a doctor

  • Other information

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

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

  • Questions?

    1-800-275-3433

  • PRINCIPAL DISPLAY PANEL – Pac-Kit 12 count box

    PAC-KIT
    FIRST AID

    First Aid
    Burn Cream
    Packets

    Paquetes de crema
    para quemaduras

    12 First Aid Burn
    Cream Packets,
    0.9gm ea.

    12 paquetes,
    0,9 gm cada uno.

    Reorder #13-006

    ANSI Z308. 1-2009

    PRINCIPAL DISPLAY PANEL – Pac-Kit 12 count box
  • INGREDIENTS AND APPEARANCE
    FIRST AID AND BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 g
    lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) lidocaine hydrochloride5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    alcohol (UNII: 3K9958V90M)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    petrolatum (UNII: 4T6H12BN9U)  
    white wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5701-0512 in 1 BOX
    1NDC:0924-5701-010.9 g in 1 PACKET
    2NDC:0924-5701-0625 in 1 BOX
    2NDC:0924-5701-010.9 g in 1 PACKET
    3NDC:0924-5701-0760 in 1 BOX
    3NDC:0924-5701-010.9 g in 1 PACKET
    4NDC:0924-5701-08144 in 1 BOX
    4NDC:0924-5701-010.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/27/2012
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-5701)
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