Label: THERAWORX PAIN RELIEF ROLL-ON WITH LIDOCAINE FOR DIABETICS- lidocaine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Drug Facts

  • Active Ingredient

    Lidocaine Hydrochloride 4.00%

    Purpose

    Topical analgesic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only.

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas.

    When using this product

    avoid contact with the eyes.

    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.

    If pregnant or breastfeeding,

    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 2 years of age and older: 
    • shake bottle well 
    • roll a thin layer to each affected area and allow to air dry 
    • repeat 
    • Wash hands after applying product 
    • do not use more than 3 to 4 times daily 
    • children under 2 years of age do not use: consult a doctor
  • Other Information

    Store between 32°F and 120°F

  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    THERAWORX PAIN RELIEF ROLL-ON WITH LIDOCAINE FOR DIABETICS 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-030
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-030-0074 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2024
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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