Numb 520

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

Medically reviewed by Drugs.com. Last updated on Jan 3, 2023.

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63742-002
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (LIDOCAINE)	LIDOCAINE	5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER
TROLAMINE
PROPYLENE GLYCOL
BENZYL ALCOHOL
DIETHYLENE GLYCOL MONOETHYL ETHER
NEOPENTYL GLYCOL DICAPRATE
TRIDECETH-10
CHOLESTEROL
ALLANTOIN
.ALPHA.-TOCOPHEROL ACETATE
POLYSORBATE 80

Packaging
#	Item Code	Package Description
1	NDC:63742-002-01	1 BOTTLE in 1 PACKAGE
1		38 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/18/2015

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Operations
Clinical Resolution Laboratory, Inc.		825047942	manufacture(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