NUMB520- lidocaine hydrochloride, phenylephrine hydrochloride spray 
Clinical Resolution Laboratory, Inc.

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Numb520 Spray

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

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

Other Information

Inactive Ingredients

Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

Package Labeling:

Label

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)

Revised: 12/2023
Document Id: 0d76f485-b7e3-50a6-e063-6294a90a56aa
Set id: d88d5250-2fc1-46da-a312-a2542e226c5d
Version: 2
Effective Time: 20231226
 
Clinical Resolution Laboratory, Inc.