LIDOCAINE PAIN RELIEVING GEL-PATCH- lidocaine 4% patch 
Noble OTC LLC

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Noble Lidocaine 4% Pain Relieving Gel-Patch

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

For temporary relief of pain

Warnings

For External Use Only

Stop use and ask a doctor

Keep out of the reach of children

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

Do Not Use

If Pregnant or Breast-Feeding

Ask a health professional before use

When Using this product

Directions

Adult and children 12 years of age and over:

Other information

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

Noble Lidocaine patch CDER

LIDOCAINE PAIN RELIEVING GEL-PATCH 
lidocaine 4% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81533-201-055 in 1 BOX02/28/2024
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/28/2024
Labeler - Noble OTC LLC (041836435)
Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 3/2024
Document Id: 12a3ce73-a956-d545-e063-6394a90a845b
Set id: 12a3ce63-6fce-0993-e063-6294a90a40d5
Version: 1
Effective Time: 20240301
 
Noble OTC LLC