Label: NUMB520- lidocaine liquid

  • NDC Code(s): 63742-006-00, 63742-006-01
  • 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 5%

    Purpose

    Local Anesthetic

  • Uses:

    Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

  • Warnings

    (For external use only)

    Do not use this product if

    • Pregnant or breastfeeding, ask a health professional before use
    • Tamper-evident shrink band around the container is broken.

    When using this product

    • Do not exceed the recommended daily 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.
    • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

    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

    • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
    • Apply up to 6 times a day.
    • Children under 12 year 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, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    NUMB520 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-006-00123 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2018
    2NDC:63742-006-01251 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/15/2018
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
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