Label: NUMB520- lidocaine hydrochloride cream

  • NDC Code(s): 63742-030-00, 63742-030-01
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • DRUG FACTS

  • Active Ingredient

    Lidocaine HCl 5%

    Purpose

    Local Anesthetic

  • Uses:

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

  • Warnings

    (For external use only)

    Do not use this product if

    • pregnant or breastfeeding, ask a health professional before use.
    • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
    • tamper evident "Do not use this product" if seal is broken or missing.

    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 finger 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 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 (59-86°F/15-30°C)
  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

  • Package Labeling:

    Label

  • Package Labeling: (63742-030-01)

    Label2

  • INGREDIENTS AND APPEARANCE
    NUMB520 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALLANTOIN (UNII: 344S277G0Z)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-030-00125 g in 1 BOTTLE; Type 0: Not a Combination Product09/12/2019
    2NDC:63742-030-0139 g in 1 JAR; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01509/12/2019
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Resolution Laboratory, Inc.825047942manufacture(63742-030) , label(63742-030) , pack(63742-030)
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