Otc - Active Ingredient
Menthol 5%
Herbal Healers Menthol Warming Roll On
FDA Label NDC 76348-581
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 Herbal Healers Menthol Warming Roll On (NDC 76348-581). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
Uses for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
Warnings
For external use only
Otc - When Using
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 of if symptoms persist for more then 7 days or clear p 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 or as directed by your doctor
children under 12 years of age, do not use. Consult a healthcare professional.
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Hemp Derived Cannabigerol (CBG) Extract with proprietary terpene blend (Alpha Pinene, Beta Caryophyllene, Myrcene, Limonene, Linalool, Terpinolene), Capsicum frutescens extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Hydroxyethyl Celluose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).
Otc - Questions
Questions ? www.HerbalHealersCBD.com
Statement Of Identity
HERBAL HEALERS
Menthol WARMING
Pain Relief
Roll-On
Package Label.Principal Display Panel
WARMING PAIN RELIEF ROLL-ON LABEL AND BOX
Hh Box (Box)
* Please review the disclaimer below.
