FDA Label for Cold Therapy Pain Relief Medicated Gnp
View Indications, Usage & Precautions
Cold Therapy Pain Relief Medicated Gnp Product Label
The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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 Purpose
Menthol 10.5% ....................... . ........... Topical Analgesic
Uses
Temporary relief from minor aches and pains of muscles and joints associated with arthrttis, simple backache, strains and sprains
Wamings For External Use Only.
Flammable: Do not use while smo~ng or near heat or flame.
When using this product • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged skin • do not apply
to the irritated skin • do not bandage • wash hands atter use with cool water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or tt symptoms persist for more than 7 days, or clear up and reoccur again within a few days.
Keep Out Of Reach Of Children.
If accidentally ingested get medical help or contact a Poison Control Center immediately.
Directions
• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.• Children under 2 years of age: Consult physician.
Inactive Ingredients
Alcohol Denat.,Arnica Montana Flower Extract, Calendula Officinalis
Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita
Flower Extract, Dimethyl Sulfone, EchinaceaAngustifolia Extract,
llex Paraguariensis Leaf Extract, lsopropyl Myristate, Juniperus
Communis Fruit Extract, Water
Questions?
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