Label: THERACARE 4% LIDOCAINE CREAM- lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 5, 2022

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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 not finalpart34812/01/2022
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-933)
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