FDA Label for Cool Hot Ice Analgesic Gel
View Indications, Usage & Precautions
Cool Hot Ice Analgesic Gel Product Label
The following document was submitted to the FDA by the labeler of this product Shield Line Llc. 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
Menthol 1.0%
Purpose
Topical Analgesic
Uses:
- temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries
Warnings
FOR EXTERNAL USE ONLY
Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.
Do Not Use With Heating Pads Or Heating Devices
If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, get medical help or contact a Poison Control Center right away
Directions
Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.
Inactive Ingredients
Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1
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