Active Ingredient
Menthol 2%..................... Topical Analgesic
Camphor 3%................... Topical Analgesic
Hielo Mineral
FDA Label NDC 65112-261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I Shay Cosmetics Inc for the product Hielo Mineral (NDC 65112-261). 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 ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, inactive ingredients, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (Hilelo1)
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