Purpose
Camphor 11% ……………………………………………………………………………………Topical analgesic
Menthol 16% ………………..……………………………………………………………………Topical analgesic
Icy Hot Performance Dry Spray
FDA Label NDC 41167-0810
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 Performance Dry (NDC 41167-0810). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises
Warnings
For external use only
Extremely flammable: keep away from fire, sparks, and heated surfaces. Contents under pressure, do not puncture or incinerate container. Exposure to temperatures above 120°F may cause bursting.
Do Not Use
■ on wounds or on irritated or damaged skin
■ with a heating pad
When Using This Product
■ use only as directed. Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes. Do not spray in face or mouth.
■ do not expose the area to local heat or direct sunlight
■ rare cases of serious burns have been reported with products of this type
■ 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 or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ redness is present or excessive skin irritation occurs
■ you experience severe burning 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.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ adults and children 12 years of age and older:
■ spray the affected area not more than 3 to 4 times daily
■ product will dry quickly on its own, and does not need to be rubbed in
■ wash hands thoroughly with soap and water after each use
■ children under 12 years of age: ask a doctor
Inactive Ingredients
alcohol denat., glycerin, isobutane, propylene glycol, water
Principal Display Panel
Icy Hot
Performance
Dry Spray
Pain Relief
Net Wt
4 OZ (113 G)
Principal Display Panelicy Hotperformancedry Spraypain Reliefnet Wt4 Oz (113 G) (Icy Hot Performance Dry Spray 01)
* Please review the disclaimer below.
