MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH- lidocaine patch 
Manamed, Inc.

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Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do not use

When using is product

Stop use and consult a doctor if

If pregnant or breastfeading, ask health professional before use.

Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.Use one patch for up to 8 hrs

Children under 12 years of age : consult a physician

Other information

Store in clean, dry place outside of direact sunlight. Protect from excessive moisture.

Inactive ingredients

Water, Glycerin, Propylene Glycol, PVP, Sodium Polyacrylate, Methylparaben, Propylparaben, Aluminum Glycinate, Kaolin, Polyacrylic Acid, Polysorbate 80, Tartaric Acid, Titanium Dioxide

Product label

image descriptionimage description

MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82728-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82728-001-016 in 1 BOX06/22/2022
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/22/2022
Labeler - Manamed, Inc. (084042331)

Revised: 12/2023
Document Id: 0cf48d47-5f3b-bfd6-e063-6394a90ac5cb
Set id: 78d8ba4d-e9bc-40ec-9eb4-7e715ac68d5c
Version: 3
Effective Time: 20231220
 
Manamed, Inc.