Otc - Active Ingredient
Menthol 2.5%
Hempe Ice Muscle And Joint Gel
FDA Label NDC 87916-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healthcare International Research Limited for the product Hempe Ice Muscle And Joint Gel (NDC 87916-001). 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 otc - active ingredient, otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
If symptoms persist for more than 7 days
Otc - Do Not Use
In the mouth. In the eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant consult your doctor.
Dosage & Administration
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 : do not use, consult a doctor. Massage until absorbed by the skin.
Inactive Ingredient
lnactive lngredients • Aqua, Alcohol Denat., Glycerin, Menthol, Sodium Polyacrylate, Hydrogenated Polydecene, PEG-35 Castor Oil, Hemp Seed Oil, PEG-8 Dimethicone, Tocopherol (Vitamin E), Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Mentha Arvensis Herb Oil (Wild Mint), Mentha Piperita Oil (Peppermint), Trideceth-6, Cannabidiol (CBD), Pinus Sylvestris Twig Leaf Oil (Pine), Laurus Nobilis Leaf Oil (Bay Leaf), Limonene, Linalool, Sodium Chloride, Sodium Sulfate, CI 42090.
Warnings
Warnings - For external use only. Test on a small area of skin before full application. Protect from sunlight. Store in a cool dry place. Wash hands after use. If pregnant consult your doctor.
Indications & Usage
Temporary relief of minor aches and pains of muslces and joints associated with simple bachache, arthirits, strains, bruises and sprains
Otc - Purpose
Topical analgesic
Package Label.Principal Display Panel
HEMPE ICE Muscle and Joint Gel
HEMPE ICE label for 150 mL and 50 mL
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