LIDOCAINE PAIN RELIEVING GEL-PATCH- lidocaine 4% patch

Lidocaine Pain Relieving Gel-Patch by

Drug Labeling and Warnings

Lidocaine Pain Relieving Gel-Patch by is a Otc medication manufactured, distributed, or labeled by Noble OTC LLC, Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

INDICATIONS & USAGE

For temporary relief of pain

Warnings

For External Use Only

Stop use and ask a doctor

• Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Condition worsens
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

• More than 1 patch at a time
• On wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product

If Pregnant or Breast-Feeding

Ask a health professional before use

When Using this product

• Use only as directed
• Avoid contact with eyes, mucous membranes or rashes
• Do not bandage tightly

Directions

Adult and children 12 years of age and over:

• Clean and dry affected area
• Remove film from patch and apply to the skin
• Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• Remove patch from teh skin after at most 8-hour application
• Children under 12 years of age. Consult a doctor

Other information

• Store at controlled room temperature 68º-77ºF (20º-25ºC)
• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions or Comments

Call (347) 378-8990

M-F 9-5 or by email info@nobleotc.com

Distributed By

Manufactured For

Noble OTC LLC

Upper Saddle River, NJ 07458

www.nobleotc.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEVING GEL-PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81533-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
KAOLIN (UNII: 24H4NWX5CO)
EDETATE SODIUM (UNII: MP1J8420LU)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81533-201-05	5 in 1 BOX	02/28/2024
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/28/2024

Labeler - Noble OTC LLC (041836435)

Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)