ICY HOT WITH LIDOCAINE- lidocaine and menthol patch

Icy Hot with Lidocaine by

Drug Labeling and Warnings

Icy Hot 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

ICY HOT with 4% LIDOCAINE PATCH

Drug Facts

Active ingredients 

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

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

■ avoid contact with the eyes and mucous membranes

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

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ 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

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ 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, PEG-40 hydrogenated castor oil, polyacrylic acid, polysorbate 80, propylene glycol, ricinus communis (castor) seed oil, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water 

Child-resistant packaging.

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

ICYHOT
LIDOCAINE PATCH
PLUS MENTHOL

INGREDIENTS AND APPEARANCE

ICY HOT WITH LIDOCAINE 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	240 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 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)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASTOR OIL (UNII: D5340Y2I9G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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: 41167-1720-1	5 in 1 CARTON; Type 0: Not a Combination Product	02/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/18/2018

Labeler - Chattem, Inc. (003336013)