Label: WALGREENS COOL N HEAT LIDOCAINE- lidocaine hcl 4% gel

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

Drug Label Information

Updated December 27, 2023

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  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    For the temporary relief of pain.

  • WARNINGS

    For external use only.

    Flammable.Keep away from fire or flame.

    Do not use inlarge quantities, particularly over raw surfaces or blistered areas.

    When using this product

    • avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again with a few days
    • redness or irritation develops
  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Clean affected area before applying product. Adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years old, ask a doctor.

  • INACTIVE INGREDIENT

    Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf extract, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21 water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL N HEAT LIDOCAINE 
    lidocaine hcl 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7801
    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)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7801-0271 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/27/2023
    Labeler - Walgreens Co (008965063)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(0363-7801)
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