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 March 8, 2022

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  • Active ingredient

    Lidocaine HCI (2%)

  • Purpose

    Topical Pain Relief

  • Uses

    Temporary pain relief of minor burns. For professional use only.

  • 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 large quantities, particularly over raw or blistered areas
    • near eyes, if this happens, rinse thoroughly with water

    Stop use and ask a doctor if

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

    • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: 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, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

  • Questions or Comments?

    1-800-456-7077

  • Principal Display Panel - 0.9g Box Label

    NDC 70082-500-01

    dealmed

    Burn
    Gel

    For temporary relief
    of minor burns

    144
    PACKETS

    NET WT. 0.9g
    PER PACKET

    Principal Display Panel - 0.9g Box Label
  • Principal Display Panel - 0.9g Pouch Label

    dealmed

    Burn Gel

    0.9g (1/32 oz.)

    Dealmed • Brooklyn, NY

    www.dealmed.com

    Principal Display Panel - 0.9g Pouch Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70082-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous18 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:70082-500-01144 in 1 BOX03/18/2022
    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 finalpart34803/18/2022
    Labeler - Dealmed Medical Supplies LLC (068586441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(70082-500)
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