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 March 9, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid Antiseptic

    External analgesic

  • Uses

    first aid to help prevent infection and for the temporary relief of itching associated with

    • minor cuts
    • scrapes
    • burns
  • 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.

  • 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
  • Other information

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

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

  • Questions? 1-800-835-2263

    REORDER
    www.PhysiciansCareFirstAid.com
    1 800 835 2263

  • Principal Display Panel - Packet Label

    FIRST AID ONLY®

    Burn Cream

    NET WT 1/32 oz (0.9g)

    © 2015 Acme United Corporation.

    Faifield, CT 06824

    1.800.835.2263

    www.FirstAidOnly.com

    NDC 0924-5701-01

    Principal Display Panel - Packet Label
  • Principal Display Panel - Packet Label

    FIRST AID ONLY®

    13-006

    BURNS

    First Aid/Burn Cream

    12 (0.9g) Packets

    Ungüento de primeros auxilios/para quemaduras

    12 sobres de (0.9g)

    NDC 0924-5701-10

    Principal Display Panel - Packet Label
  • 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 HYDROCHLORIDE ANHYDROUS5 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:0924-5701-0410 in 1 BOX
    1NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5701-0910 in 1 BOX
    2NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5701-1012 in 1 BOX
    3NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5701-1125 in 1 BOX
    4NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5701-12144 in 1 BOX
    5NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5701-1360 in 1 BOX
    6NDC:0924-5701-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    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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