ASPERCREME WITH LIDOCAINE XL- lidocaine patch

Aspercreme with Lidocaine by

Drug Labeling and Warnings

Aspercreme with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ASPERCREME LIDOCAINE PATCH XL

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

■ more than 1 patch on your body at a time or on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton/label. (change as appropriate)

■ do not allow contact with the eyes and mucous membranes

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not use at the same time as other topical analgesics

■ 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

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ 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 for up to 12 hours

children 12 years or younger: ask a doctor

Inactive ingredients

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

PRINCIPAL DISPLAY PANEL

Aspercreme
Lidocaine
Patch XL

INGREDIENTS AND APPEARANCE

ASPERCREME WITH LIDOCAINE  XL
lidocaine patch

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

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

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0585-1	4 in 1 CARTON	10/21/2017
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/21/2017

Labeler - Chattem, Inc. (003336013)