Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

on puncture wounds, cuts, irritated or swollen skin
more than 1 patch on your body at a time or with other topical analgesics at the same time
with a heating pad or apply local heat to the area of use

When using this product

use only as directed
do not bandage tightly
avoid contact with the eyes
dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a 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 over 12 years:

clean and dry affected area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
use 1 patch at a time and not more than 3 to 4 times daily

children 12 years or younger: consult a doctor

Inactive ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

PRINCIPAL DISPLAY PANEL

Aspercreme
Lidocaine Patch XL

ASPERCREME WITH LIDOCAINE XL
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0585
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	422 mg

Ingredient Name	Strength
Inactive Ingredients
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYGALIC ACID (UNII: XCC6WEA55L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0585-1	4 in 1 CARTON	10/21/2017	10/22/2017
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:41167-0585-0	3 in 1 CARTON	10/21/2017
2		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	M017	10/21/2017

Labeler - Chattem, Inc. (003336013)

Aspercreme with Lidocaine Patch XL