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 January 27, 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

    • temporary relief of pain associated with minor cuts, scrapes, burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only

    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

    Keep out of reach of children.

    If ingested contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • may be covered with a sterile bandage
  • Inactive ingredients

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

  • 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
  • PRINCIPAL DISPLAY PANEL – Physicians Care bag (0924-5701-03)

    Item # 806031

    PhysiciansCARE

    FIRST AID & BURN
    CREAM PACKETS

    ANSI Z308.1-2003R

    Contents: 6 Single Use Packets

    0.9 gr. (1/32 fl. oz.)

    See reverse for Drug Facts.

    Distributed by Acme United Corporation

    Fairfield, CT 06824 · 800-835-2263

    PRINCIPAL DISPLAY PANEL – Physicians Care bag (0924-5701-03)
  • PRINCIPAL DISPLAY PANEL – Pac-Kit bag (0924-5701-02)

    Unit 13-006 B

    PAC-KIT FIRST AID

    FIRST AID & BURN
    CREAM PACKETS

    ANSI Z308.1-2003R

    Contents: 6 Single Use Packets

    0.9 gr. (1/32 fl. oz.)

    See reverse for Drug Facts.

    Distributed by Acme United Corporation

    Fairfield, CT 06824 · 800-835-2263

    PRINCIPAL DISPLAY PANEL – Pac-Kit bag (0924-5701-02)
  • 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:0924-5701-026 in 1 BAG
    1NDC:0924-5701-010.9 g in 1 PACKET
    2NDC:0924-5701-036 in 1 BAG
    2NDC: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
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