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

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

Drug Label Information

Updated October 23, 2023

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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

    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:

    Label0

  • INGREDIENTS AND APPEARANCE
    THERAWORX PAIN RELIEF ROLL- ON- LIDOCAINE 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-028
    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:61594-028-001 in 1 CARTON01/15/2024
    174 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2024
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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