ICY HOT LIDOCAINE DRY- lidocaine, menthol spray

Icy Hot Lidocaine Dry by

Drug Labeling and Warnings

Icy Hot Lidocaine Dry 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 LIDOCAINE DRY SPRAY

Drug Facts

Active ingredients

Purposes

Lidocaine 4%....................................................................................................................................Topical anesthetic

Menthol 1%........................................................................................................................................Topical analgesic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

■ on large areas of the body 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 label.

■ do not allow contact with the eyes and mucous membranes

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

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

■ avoid spraying on face

■ avoid inhalation of spray

■ do not bandage or apply local heat (such as heating pads) or a medicated patch to 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

■ avoid applying into skin folds

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

Extremely Flammable

■ do not use near heat or flame or while smoking

■ avoid long term storage above 104°F (40°C)

■ do not puncture or incinerate. Contents under pressure.

■ do not store at temperatures above 120°F (49°C)

If pregnant or breast-feeding,

ask a health 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:

■ spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

■ product will dry quickly on its own, and does not need to be rubbed in

children 12 years or younger: ask a doctor

Inactive ingredients:

alcohol denat. (30%), caprylic/capric triglyceride, isobutane, propylene glycol

PRINCIPAL DISPLAY PANEL

MAX STRENGTH LIDOCAINE
NEW
ICY HOT
LIDOCAINE
PLUS MENTHOL
DRY
SPRAY
NET WT 4 OZ (113 g) Pain Relief Spray

INGREDIENTS AND APPEARANCE

ICY HOT LIDOCAINE DRY 
lidocaine, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1740
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOBUTANE (UNII: BXR49TP611)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1740-2	113 mL in 1 CAN; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/01/2019

Labeler - Chattem, Inc. (003336013)