NUMB MASTER TOPICAL ANESTHETIC (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]

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NUMB MASTER TOPICAL ANESTHETIC (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]
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NDC 63742-001-00
Set ID 6d2428fc-4680-4dbd-9419-0374ea5a5060
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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  • NUMB MASTER Topical Anesthetic Cream


  • Active Ingredient

    Lidocaine 5%

    Purpose

    Local Anesthetic

  • Uses

    for the temporary relief of local or 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 mechanical device or applicator.

    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 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 Informations

    • Keep away from direct sunlight or heat
    • Store in room temperature (59-86oF / 15-30oC)
  • Inactive Ingredients

    Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin.

  • Manufactured by

    CLINICAL RESOLUTION LABORATORY, INC.  Brea, CA 92821   Made in U.S.A.  CLINICAL RESOLUTION   Do not use if seal is broken   CLINICAL RESOLUTION MICRONEEDLE THERAPY SYSTEM

  • NUMB MASTER Topical Anesthetic Cream

    Numb Master 1Numb Master 2

  • INGREDIENTS AND APPEARANCE
    NUMB MASTER TOPICAL ANESTHETIC 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-001
    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
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-001-00118 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/24/2014
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Resolution Laboratory, Inc.825047942manufacture(63742-001)
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