Label: LIDOCAINE HYDROCHLORIDE gel

  • 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 November 11, 2013

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  • Active Ingredient

    Benzalkonium

    Chloride 0.13% ...

    Lidocaine

    HCl 0.5%

  • Purpose

    First aid

    antiseptic

    Topical

    analgesic

  • Uses

    • temporary relief of pain associated with minor 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
    • children under 2: consult a doctor
  • Inactive Ingredients

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

  • Principal Display Panel – 0.9 g Packet Label

    First Aid Burn Cream

    The Provision
    First Aid
    Line™

    For Burns
    and Cuts

    0.9 g (1/32 oz.)

    Principal Display Panel – 0.9 g Packet Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    water (UNII: 059QF0KO0R)  
    menthol (UNII: L7T10EIP3A)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-5000-00.9 g in 1 PACKET; Type 0: Not a Combination Product07/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/25/2022
    Labeler - Provision Medical (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-5000)
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