FDA Label for Icy Hot Lidocaine Dry

View Indications, Usage & Precautions

Icy Hot Lidocaine Dry Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.