FDA Label for Solid Roots Roll-on Relief
View Indications, Usage & Precautions
Solid Roots Roll-on Relief Product Label
The following document was submitted to the FDA by the labeler of this product Renu Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Menthol 3 percent
Otc - Purpose
Topical Anesthetic
Indications & Usage
Uses
for temporary relief of minor aches and pains of muscles and joints associated with
- bruises
- sprains
- arthritis
- strains
Recent Major Changes
Change that is not substantive (Date change for a cloned submission
Dosage and Administration - only a date change
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 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
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children twelve years of age and older,
apply to affected area no more than ten times a day as needed for pain
children under twelve years of age do not use, consult a doctor
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)
Otc - Questions
Questions? Comments ?
AUTHENTIC BLENDS, LLC
HAVERTOWN, PA 19083
Product Multi-Layer Label Page 1 Of 3 Page 2 Of 3 Page 3 Of 3
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