Label: LIDOSTAT- lidocaine hcl cream

  • NDC Code(s): 44577-704-02
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • LidoStat CREAM


  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    External Anesthetic

  • Uses:

    For temporary relief of pain and itching caused by minor skin irritations.

  • Warnings:

    For external use only.

    Do not use

    on children under 2 years of age unless directed by a physician.

    When using this product

    avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if:

    • symptoms persist for more than seven days, or clear up and occur again within a few days.
    • redness, irritation, swelling, pain or other symptoms increase

    Keep out of reach of children.

    If swallowed, consult a physician.

  • Directions:

    For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

    Children under 2 years of age: Ask a doctor.

  • Other information:

    Store at room temperature (68-77ºF) (20º-25ºC)

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.

  • Question or Comments?

    Please visit www.BakoCTS.com

  • LidoStatTM Cream

    Distributed by: CLINICAL THERAPEUTIC SOLUTIONS A Part of bako's Integrated Physician Solution PO Box 1257, Wall, NJ 07719 732.894.9450 •



    www.BakoCTS.com

  • PRINCIPAL DISPLAY PANEL

    LidoStat CREAM

    Lidocaine HCI 4% In a 20% Urea Vehicle MEDICAL STRENGTH PAIN CREAM


    PENETRATING FORMULA

    Dipensed Only by Physicians

    NET WT. 2.0 oz (56 g)

    LOT:

    EXP:

  • LidoStat CREAM 2oz/56g (44577-704-02)

    Inner LabelOuter Label

  • INGREDIENTS AND APPEARANCE
    LIDOSTAT  
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-704-021 in 1 CARTON02/07/2017
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/19/2013
    Labeler - Clinical Therapeutic Solutions (078402750)
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