Active Ingredients
Camphor 11%
Menthol 16%
Icy Hot Performance No-mess Pain Relief Cream
FDA Label NDC 41167-0725
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 No-mess Pain Relief Cream (NDC 41167-0725). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Topical analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises
Warnings
For external use only
Do Not Use
■ on wounds or on irritated or damaged skin
■ with a heating pad
When Using This Product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ 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:
■ apply to affected area not more than 3 to 4 times daily
■ remove protective cap and lift blue applicator at arrows
■ squeeze tube gently while holding upright to dispense a small amount of product
■ press down to close applicator prior to application
■ massage product into skin using applicator until thoroughly absorbed
■ if needed, clean applicator by rinsing with water or wipe clean with a cloth
■ wash hands thoroughly with soap and water if product comes in contact with hands
■ children under 12 years of age: ask a doctor
Inactive Ingredients
4-t-butylcyclohexanol, acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., allantoin, aloe barbadensis leaf juice, cetyl alcohol, citrus paradisi (grapefruit) peel oil, farnesol, fragrance, glyceryl stearate, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, pentylene glycol, potassium hydroxide, propanediol, steareth-21, stearic acid, water
Close cap tightly after use.
Principal Display Panel
Icy Hot
Performance
No Mess
Cream Pain Relief
Principal Display Panelicy Hotperformanceno Mess Cream Pain Relief (Icy Hot Performance No Mess Cream 01)
* Please review the disclaimer below.
