FDA Label for Hielo Mineral
View Indications, Usage & Precautions
Hielo Mineral Product Label
The following document was submitted to the FDA by the labeler of this product I Shay Cosmetics 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
Menthol 2%..................... Topical Analgesic
Camphor 3%................... Topical Analgesic
Otc - Purpose
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.
Otc - Keep Out Of Reach Of Children
WARNINGS - Keep out of reach of children
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.
Inactive Ingredients
Ethanol, Water, Methyl Salicylate, Hydrogenated Castor Oil, FD&C Blue No. 1.
Warnings
For external use only
Avoid contact with eyes
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not apply to wounds or damaged skin
Do not bandage tightly
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 ands children 2 years of age and older: Spray to affected area not more than 3 to 4 times daily. Leave it on.
Children under 2 years of age: Consult a physician
Other Information
Store at room temperature between 15 °and 30°C (59°-86°F)
Label
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