Purpose
Menthol 16%......................................................................................................................................Topical analgesic
Icy Hot Dry Spray
FDA Label NDC 41167-0815
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot Dry (NDC 41167-0815). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains
■ sprains ■ bruises ■ cramps
Warnings
For external use only
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
■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ do not expose the area treated with product to heat or direct sunlight
■ 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 with desired amount of product
■ product will dry quickly on its own, and does not need to be rubbed in
■ repeat as necessary, but no more than 3 to 4 times daily
■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
children 12 years or younger: ask a doctor
Inactive Ingredients:
alcohol denat. (55%), glycerin, isobutane, propylene glycol, water
Principal Display Panel
IcyHot
Dry
Spray
16% Menthol
NET WT 4 OZ (113g)
Principal Display Panelicyhotdryspray16% Mentholnet Wt 4 Oz (113g) (Icy Hot Dry Spray 01)
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