Label: THERACARE PAIN RELIEVING LIDOCAINE CREAM- lidocaine hydrochloride cream

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

Drug Label Information

Updated October 10, 2024

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  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only. Avoid contact with eyes.

    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 on this carton.
    • do not allow contact with the eyes and mucus membranes
    • do not bandage or apply local heat (such as heating pads) to the area of use

    Stop use and ask a doctor if

    • condition worsens
    • 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 (800-222-1222) 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

  • Inactive ingredients

    Inactive ingredients

    aloe vera extract, cetostearyl alcohol, dimethicone, edetate d sod um anhydrous, ethyl alcohol, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iodopropynyl butylcarbamate, monostearin, phenoxyethanol, polyacrylic acid, potassium hydroxide, steareth-2, steareth-21, tween 60, water

  • PRINCIPAL DISPLAY PANEL TheraCare 4% Lidocaine Cream

    Pack

  • INGREDIENTS AND APPEARANCE
    THERACARE PAIN RELIEVING LIDOCAINE CREAM 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    STEARETH-2 (UNII: V56DFE46J5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-057-011 in 1 CARTON10/01/2024
    176.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(71101-057)
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