Label: LIDOCAINE HYDROCHLORIDE gel

  • 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 7, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 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 directly

    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 doctor if

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

    Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

    Children under 2 years: do not use, consult a doctor

  • Other information

    • store at room temperature (do not freeze)
    • do not use any opened or torn packs
  • Inactive ingredients

    aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, Vitamin E acetate

  • Principal Display Panel - Pouch Label

    FIRST AID ONLY®

    Burn Gel

    For Temporary
    Pain Relief of
    Minor Burns

    NET WT 3.5g

    Distributed by

    © 2016 Acme United Corporation.

    Fairfield, CT 06824

    1.800.835.2263

    www.FirstAidOnly.com

    Principal Display Panel - Pouch Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5000
    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:0924-5000-016 in 1 BOX02/14/2013
    1NDC:0924-5000-003.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5000-0225 in 1 BOX02/14/2013
    2NDC:0924-5000-003.5 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 finalpart34802/14/2013
    Labeler - Acme United Corporation (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0924-5000)
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