Label: NUMB520- lidocaine hydrochloride, phenylephrine hydrochloride spray

  • NDC Code(s): 63742-012-00
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • DRUG FACTS

  • Active Ingredients

    Lidocaine HCL 5%

    Phenylephrine HCL, 0.25%

    Purpose

    Local Anesthetic

    Vasoconstrictor

  • Uses:

    For the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.

  • Warnings

    • for external use only.
    • avoid contact with the eyes.

    keep out of reach of children.

    Do not use this product if

    • pregnant or breastfeeding, ask a health professional before use.
    • Tamper Evident "Do not use this product" if safety seal is broken or missing.
    • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

    When using this product

    • do not exceed the recommended daily usage.
    • 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.
    • if swallowed, call your Poison Control Center at 1(800) 222-1222.
    • if condition worsens or does not improve within 7 days, consult a doctor.

    Stop use and ask a doctor if

    • the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Directions

    • clean the affected area.
    • sensitivity and possible allergy tests advised prior to use. Spray spraingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
    • apply to the affected area up to 4 times daily.
    • 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, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    NUMB520 
    lidocaine hydrochloride, phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ARGININE (UNII: 94ZLA3W45F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-012-0072 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/01/2019
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!