NUMB MASTER- lidocaine cream

Numb Master by

Drug Labeling and Warnings

Numb Master by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (59-86 ​0​F / 15-30 ​0​C)

Inactive Ingredients

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

​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 sunlinght or heat
• Store in room temperature (59-86°F / 15-30°C)

​Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin

Package Labeling - 28.53g

Package Labeling - 118g

INGREDIENTS AND APPEARANCE

NUMB MASTER 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-001-01	1 in 1 PACKAGE	12/18/2015
1		28.53 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63742-001-00	118 g in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/24/2014

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-001)