Label: FIRST AID- benzalkonium chloride and lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 2, 2014

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  • Active ingredient (in each gram)

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    • temporary relief of pain associated with minor burns, cuts and scrapes
    • 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

    Manufactured for:
    Provision Medical Products
    Palm Desert, CA 92211

  • Principal Display Panel - Pouch Label

    TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

    cream Relieves Pain and Helps Prevent Infection

    First Aid and Burn 0.9g

    The Provision
    First Aid
    Line™

    Principal Display Panel - Pouch Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID 
    benzalkonium chloride and lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3553
    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 (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine5.0 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:69103-3553-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/02/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-3553)
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