Otc - Active Ingredient
Menthol 2.5%
Hempe Hot Muscle And Joint Gel
FDA Label NDC 87916-002
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 Hot Muscle And Joint Gel (NDC 87916-002). 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 - purpose, otc - do not use, otc - stop use, instructions for use, inactive ingredient, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Otc - Do Not Use
Do not use • In the mouth • In the eyes. Do not apply to open wounds or damaged skin • Do not bandage tightly
Otc - Stop Use
If symptoms persist for more than 2 days
Instructions For Use
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 skin.
Inactive Ingredient
lnactive lngredients • Aqua, Alcohol Denat., Glycerin, PEG-35 Castor Oil, Sodium Polyacrylate, Eugenia Caryophyllus leaf Oil (Clove leaf), Hydrogenated Polydecene, Eugenol (Clove Oil), Hemp Seed Oil, PEG-8 Dimethicone, Tocopherol (Vitamin E), Vanillyl Butyl Ether, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Trideceth-6, Cannabidiol (CBD), Eucalyptus Globulus leaf Oil (Eucalyptus), limonene, Geraniol, Sodium Chloride, Sodium Sulfate, CI 16255.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Temporary relief of minor aches and pains of muscles, joints, associated with simple backache, arthritis, strains, bruises, sprains
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 skin.
Warnings
Warnings • For external use only • Test on 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
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