NUMB MASTER TOPICAL ANESTHETIC- lidocaine cream

NUMB MASTER Topical Anesthetic by

Drug Labeling and Warnings

NUMB MASTER Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NUMB MASTER Topical Anesthetic Cream

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses

for the temporary relief of local or anorectal discomfort 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 mechanical device or applicator.
  

The symptom being treated does not subside or if redness, irritation, swelling, 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 Informations

• Keep away from direct sunlight or heat
• Store in room temperature (59-86oF / 15-30oC)
  

Inactive Ingredients

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

Manufactured by

CLINICAL RESOLUTION LABORATORY, INC.  Brea, CA 92821   Made in U.S.A.  CLINICAL RESOLUTION   Do not use if seal is broken   CLINICAL RESOLUTION MICRONEEDLE THERAPY SYSTEM

NUMB MASTER Topical Anesthetic Cream

INGREDIENTS AND APPEARANCE

NUMB MASTER TOPICAL ANESTHETIC 
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 g  in 100 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 DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TRIDECETH-10 (UNII: G624N6MSBA)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-001-00	118 g in 1 BOTTLE

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)