LIDOCAINE PAIN RELIEF patch

Lidocaine Pain Relief by

Drug Labeling and Warnings

Lidocaine Pain Relief by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC dba PAI Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Lidocaine 4%

Purpose

Topical anesthetic

Uses

Temporary relief of pain

Warnings

For external use only

Do not use

• more than one patch at a time
• on wounds or damaged, broken or irritated skin
• if you are allergic to any ingredients of this product
  

When using this product

• use only as directed           read and follow all directions and warnings
  

• do not allow contact with eyes and mucous membranes
  

• do not bandage tightly      do not apply local heat such as a heating pad

• do not use other topical anesthetics at the same time
  

Stop use and ask a doctor if

• localized skin reactions occur, such as rash, itching, redness, irritation,
  pain, swelling and blistering
  
• conditions worsen
  
• symptoms persist for more than 7 days
  
• symptoms clear up and occur again within a few days
  

if pregnant or breast-feeding, 

ask a healthcare professional before use.

Keep out of reach of children

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

Directions

Adults and children over 12 years:

• clean and dry affected area
• remove film from patch and apply to the skin
• apply one patch to affected area not more than 3 to 4 times a day
• remove patch from the skin after at most 12-hour application

Children under 12 years of age: consult a doctor

Inactive ingredients

dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl
alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water

Comments or Questions:

1-800-845-8210

††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.

Distributed by

 MADE IN JAPAN

C09750050222 R02/22

Principal Display Panel

lidocaine patch

Principal Display Panel - 30 patches

NDC: 0121-0970-30

Lidocaine Pain Relief Patch

4% Lidocaine / Topical Anesthetic

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEF 
lidocaine pain relief patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0970
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	560 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0970-05	12 in 1 CASE	04/03/2023
1		5 in 1 CARTON
1	NDC: 0121-0970-01	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0121-0970-30	6 in 1 CASE	07/29/2024
2		30 in 1 CARTON
2	NDC: 0121-0970-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/03/2023

Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)