FDA Label for Icy Hot Pro Pain Massaging Balm
View Indications, Usage & Precautions
Icy Hot Pro Pain Massaging Balm 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.
Active Ingredient
Camphor 11%
Menthol 16%
Purpose
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.
This product is not a toy or intended for use by children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older:
- massage into affected area using the no-mess balm not more than 3 to 4 times daily
- wash hands thoroughly with soap and water if product comes in contact with hands
- massage into affected area using the no-mess balm not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Inactive Ingredients
prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil
Close cap tightly after use. Keep carton as it contains important information.
Keep carton as it contains important information.
Principal Display Panel
ICY HOT Pro Pain Relief
Massaging Balm
NET WT 1.25 OZ (35 g)
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