Label: THERACARE 4% LIDOCAINE CREAM- lidocaine hydrochloride cream

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

Drug Label Information

Updated December 18, 2024

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  • SPL UNCLASSIFIED SECTION

    TheraCare 4% Lidocaine Cream. 2.7 oz

    Drug Facts

  • Active ingredient

    Lidocaine HCI 4%

  • Purpose

    Lidocaine HCl 4%............................................................................................................................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 warning on this carton.

    ■ do not allow contact with the eyes

    ■ 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 (1-800-222-1222) right away.

  • Directions

    adults and children over 12 years:

    ■ apply a thin layer to the 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

    aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE 4% LIDOCAINE CREAM 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-933
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-933-011 in 1 CARTON12/01/2022
    176.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2022
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-933)
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