Label: HEALTHWISE LIDOCAINE PLUS CREAM- benzyl alcohol, lidocaine hydrochloride cream

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

Drug Label Information

Updated April 25, 2024

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  • Active ingredient

    Benzyl alcohol 10%

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Use

    temporarily pain relief

  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin
    • in large quantities
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed.
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days 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:

    • clean and dry affected area
    • apply a thin layer to affected area not more than 3 to 4 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    Aloe Vera Leaf, Aminomethyl propanol, butylene glycol, Carbomer Interpolymer Type A (allyl sucrose crosslinked), ceteth-10 phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone, glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 mPa.S at 1.5%), maltodextrin, polysorbate 80, SD alcohol, steareth-21, water

  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
    • Store with lid closed tightly
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE LIDOCAINE PLUS CREAM 
    benzyl alcohol, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    STEARETH-21 (UNII: 53J3F32P58)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-037-011 in 1 CARTON04/01/2024
    185 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 DrugM01704/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71101-037)
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