Otc - Active Ingredient
Menthol 3 percent
Solid Roots Roll-on Relief
FDA Label NDC 76348-481
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 Solid Roots Roll-on Relief (NDC 76348-481). 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, recent major changes, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Product Multi-Layer Label Page 1 Of 3 Page 2 Of 3 Page 3 Of 3
LABEL IS A MULTI-LAYER. PAGE 1, PAGE 2 AND PAGE 3 ALL PART OF THE PEEL BACK LABEL
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