NUMB 520 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]

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NUMB 520 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]
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NDC 63742-002-01
Set ID f88829f2-d900-4b78-b2cc-eebd76c326cd
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 dicomfort 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, swellinh, 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 rinse 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 (59-860F / 15-300C)
  • Inactive Ingredients

    Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ehtoxydiglycol, Lecithin, Neopentyl Glycol Dicarprylate/Dicarpate, Sodiuym Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin, Benzyl Alcohol, Tocopherol Acetate, Polysorbate-80

  • Package Labeling:

    Outer

  • INGREDIENTS AND APPEARANCE
    NUMB 520 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
    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:63742-002-011 in 1 PACKAGE12/18/2015
    138 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/18/2015
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Resolution Laboratory, Inc.825047942manufacture(63742-002)
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