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

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MADE IN JAPAN

C09750050222 R02/22

Principal Display Panel

lidocaine-patch

lidocaine patch

LIDOCAINE PAIN RELIEF
lidocaine pain relief patch

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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

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

Labeler - PAI Holdings, LLC (044940096)

Maximum Strength Lidocaine Pain Relief Patch 4% Lidocaine ι Topical Anesthetic