Label: THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID- lidocaine hydrochloride liquid

  • NDC Code(s): 80684-098-00
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Drug Facts

  • Active ingredient

    Lidocaine HCI 4%

    Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain

  • Warnings

    For external use only.

    Flammable •keep away from fire or flame

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin • on puncture wounds • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings in this carton. • do not allow contact with the eyes and mucous membranes • do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use • do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 12 years: • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. • children 12 years or younger. ask a doctor

  • Other information

    • store at 20° - 25°C (68° - 77°F)
    • store in a cool dry place away from direct sunlight
  • Inactive ingredients

    acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol, ceteth-10 phosphate, cyclopentasiloxane, dicetyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, sd alcohol, steareth-21, water

  • Questions or comments?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-098-0074 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2024
    Labeler - Fourstar Group USA, Inc. (140099503)
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