Otc - Active Ingredient
Active ingredient
Menthol 5 percent
Inspiration Academy Menthol Cooling Roll On
FDA Label NDC 76348-950
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Inspiration Academy Menthol Cooling Roll On (NDC 76348-950). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Analgesic
Warnings
Warnings
For external use only
Otc - When Using
When using this product
Do not bandage tightly
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not use with heating pads or other heating devices.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.
- children under 12 years of age: do not use, consulta a doctor.
Recent Major Changes
THERE ARE NO SUBSTANTIVE LABELING CHANGES IN THE SECTION
- dosage and administration
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.
Otc - Questions
Questions? Comments?
www.HempforLifeWellness.com
Indications & Usage
Uses
For the temporary relief of minor aches and pains associated with sore muscles, joint discomfort strains, sprains and arthritis.
* Please review the disclaimer below.
