NUMB 100 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]

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NUMB 100 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]
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NDC 63742-003-01
Set ID e75eb3e0-853b-4b85-8c31-86cbf58effaa
Category HUMAN OTC DRUG LABEL
Packager Clinical Resolution Laboratory, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • DRUG FACTS

  • Active Ingredient

    Lidocaine 5%

    Purpose

    Local Anesthetic

  • Uses:

    For the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

  • Warnings

    (For external use only)

    Do not use

    this product if

    Pregnant or breast-feeding,

    • ask a health professional before use.
    • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
    • Tamper Evident "Warranty Void...Seal..."label atop the container is broken.

    When using this product

    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • Certain persons can develop allergic reactions to ingredients in this product.
    • Do not put this product into the rectum by using fingers or any medical device or applicator.

    Stop use and ask a doctor if

    The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention immediately.

  • Directions

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

    • Keep away from direct sunlight or heat.
    • Store in room temperature (59-86°F / 15-30°C).
  • Inactive Ingredients

    Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    NUMB 100 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-003-0138 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/18/2016
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
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