Label: WALGREENS COOL N HEAT- lidocaine 4% cream

  • NDC Code(s): 0363-3036-02, 0363-3036-04
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • ACTIVE INGREDIENT

    Lidocaine HCL 4%

    Menthol 1%

  • PURPOSE

    Topical anesthetic

    Topical anagesic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain

  • DOSAGE & ADMINISTRATION

    • Adults and children over 12 years of age: Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24 hr period.
    • Before and after applying wash hands with soap and water
    • Children under 12 years must ask a doctor

  • WARNINGS

    For external use only

    Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, or for more than one week without consulting a doctor.

  • INACTIVE INGREDIENT

    Benzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, Vitamin E, water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets

  • STOP USE

    Stop using and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within few days
    • you experience signs of skin injury such as pain, swelling, or blistering where the product was applied

  • QUESTIONS

    Questions? 1-800-925-4733

  • WHEN USING

    • Use as directed. read and follow all directions and warnings
    • rare cases of serious burns have been reported with products of this type
    • do not bandage or apply local heat to the area of use with a medicated patch
    • avoiding contact with eyes and mucus membrane
    • a transient burning sensation may occur upon application but generally disappears in several days
  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    WALGREENS COOL N HEAT 
    lidocaine 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3036-041 in 1 CARTON03/23/2022
    1133 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-3036-021 in 1 CARTON03/01/2022
    276.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2022
    Labeler - Walgreens (008965063)