Label: ANALGESIC- 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 February 25, 2019

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  • Active ingredient

    Lidocaine

    HCl 2.0%

  • Purpose

    Topical

    pain relief

  • Uses

    Temporary pain relief for minor burns

  • Warnings

    External use only. Keep out of reach of children.

    Do not use

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

    Stop use, ask a doctor

    • if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly
  • Directions

    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
    • children under 2: do not use, ask a doctor
  • Inactive ingredients

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

    Welly Health PBC, Minn., MN 55402

    1-833-BE-WELLY

  • Principal Display Panel - Welly Health Burn Gel Pouch Label

    Welly™

    Burn Gel

    0.9/ 1/32 OZ

    Principal Display Panel - Welly Health Burn Gel Pouch Label
  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    carboxypolymethylene (UNII: 0A5MM307FC)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    menthol, unspecified form (UNII: L7T10EIP3A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    .alpha.-tocopherol, d- (UNII: N9PR3490H9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-500-040.9 mL in 1 POUCH; Type 0: Not a Combination Product02/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/25/2019
    Labeler - Welly Health PBC (116766884)
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