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Numb 520

Medically reviewed by Drugs.com. Last updated on Jan 13, 2020.

Dosage form: cream
Ingredients: LIDOCAINE 5mg in 1g
Labeler: Clinical Resolution Laboratory, Inc.
NDC Code: 63742-002

Numb 520

DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

For the temporary relief of local and anorectal dicomfort 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 medical device or applicator.

Stop use and ask a doctor if

The symptom being treated does not subside or if redness, irritation, swellinh, 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 (59-860F / 15-300C)

Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ehtoxydiglycol, Lecithin, Neopentyl Glycol Dicarprylate/Dicarpate, Sodiuym Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin, Benzyl Alcohol, Tocopherol Acetate, Polysorbate-80

Package Labeling:

NUMB 520 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
TROLAMINE 
PROPYLENE GLYCOL 
BENZYL ALCOHOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
NEOPENTYL GLYCOL DICAPRATE 
TRIDECETH-10 
CHOLESTEROL 
ALLANTOIN 
.ALPHA.-TOCOPHEROL ACETATE 
POLYSORBATE 80 
Packaging
#Item CodePackage Description
1NDC:63742-002-011 BOTTLE in 1 PACKAGE
138 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/18/2015
Labeler - Clinical Resolution Laboratory, Inc. (825047942)
Establishment
NameAddressID/FEIOperations
Clinical Resolution Laboratory, Inc.825047942manufacture(63742-002)

Document Id: 9c05c0bb-95a5-fede-e053-2a95a90a1ee4
Set id: f88829f2-d900-4b78-b2cc-eebd76c326cd
Version: 3
Effective Time: 20200113
 
Clinical Resolution Laboratory, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer