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:

Outer

NUMB 520
lidocaine cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
TRIDECETH-10 (UNII: G624N6MSBA)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63742-002-01	1 in 1 PACKAGE	12/18/2015
1		38 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	12/18/2015

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Name	Address	ID/FEI	Business Operations
Establishment
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-002)

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