Label: SMART NUMB LIDOCAINE CREAM- lidocaine cream

  • NDC Code(s): 76092-201-02
  • Packager: M.J. Winston International, Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • WARNINGS

    WARNINGS

    For external use only.

    Stop use and ask a doctor if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop. If pregnant or breast-feeding, ask a health professional before use.

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Keep out of reach of children.

    WARNINGS

  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine 5% local anesthetic

    active

  • PURPOSE

    Use

    For the temporary relief of pain, burning, and soreness associted with anorectal discomfort or inflammation.

    use

  • WHEN USING

    When using this product

    Do not excceed recommended dosage unless directed by a doctor.

    when using this product

  • INSTRUCTIONS FOR USE

    Directions

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For products for external use only. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

    directions

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aacrylates, Allantoin, Arnice Montana Flower Extract, Deionized Water, Dimethyl Isosorbide, Emu Oil, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polydecene, Menthol, Phenoxythanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium Edta, Tocopheryl Acetate, Trideceth-6

    inactive

  • OTHER SAFETY INFORMATION

    Other Information

    Store at 59F to 86F (15C to 30C). Keep away from direct sunlight.

    other info

  • QUESTIONS

    Questions or concerns?

    Contact info@smartmed.us or 714-582-2715.

    questions

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    keep out of reach of children

  • DOSAGE & ADMINISTRATION

    dosage administration

  • INDICATIONS & USAGE

    Use

    For the temporary relief of pain, burning, and soreness associated with anorectal discomfort or inflammation.

    indication

  • PRINCIPAL DISPLAY PANEL

    package label principal

  • INGREDIENTS AND APPEARANCE
    SMART NUMB LIDOCAINE CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76092-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    MENTHOL (UNII: L7T10EIP3A)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EMU OIL (UNII: 344821WD61)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76092-201-0257 g in 1 JAR; Type 0: Not a Combination Product03/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/15/2024
    Labeler - M.J. Winston International, Ltd. (144927378)
    Establishment
    NameAddressID/FEIBusiness Operations
    M.J. Winston International, Ltd.144927378label(76092-201)
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