TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER- lidocaine cream

Topical Anesthetic Anorectal Cream by

Drug Labeling and Warnings

Topical Anesthetic Anorectal Cream by is a Otc medication manufactured, distributed, or labeled by Dermtech Labs Inc. dba GD Labs, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient     Purpose
Lidocaine 5%  ..... Topical Anesthetic

PURPOSE

Temporarily relieves local pain and discomfort of anorectal area.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Chilren

INDICATIONS & USAGE

Stop use and ask your doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days.

WARNINGS

• For Rectal use only
• For external use on intact skin only
• Do not use if pregnant or breast-feeding
• Do not exceed the recommended daily dosage unless directded by a doctor
• Avoid contact with eyes and mucous membranes
• You may experience temporary redness or stinging where the product is applied
• If irritation persists, consult your doctor
• Do not put product into the rectum by using fingers or any mechanical device or applicator

DOSAGE & ADMINISTRATION

• Children 12 and under, consult a physician prior to use
• When practical, clean area with mild soap and water. Rinse thoroughly and gently dry by blotting with tissue or soft cloth before applying.
• Apply to the affected area up to 6 times daily

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate-80, PPG-12/SMDI Copolyme, Propylene Glycol, Trolamine, Water

PRINCIPAL DISPLAY PANEL

Numb & Number

Topical Anesthetic

Anorectal Cream

Net Wt 20 oz / 600g

INGREDIENTS AND APPEARANCE

TOPICAL ANESTHETIC ANORECTAL CREAM  NUMB AND NUMBER
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68848-001
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68848-001-02	1 in 1 PACKAGE	08/11/2016
1	NDC: 68848-001-01	54 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 68848-001-04	1 in 1 PACKAGE	08/11/2016
2	NDC: 68848-001-03	600 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/11/2016

Labeler - Dermtech Labs Inc. dba GD Labs (148077899)

Registrant - Dermtech Labs Inc. dba GD Labs (148077899)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(68848-001)