Flexdermal Pain Relieving Roll-on Liquid
FDA Label NDC 84197-867
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Solvaderm Llc for the product Flexdermal Pain Relieving Roll-on (NDC 84197-867). 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 drug facts, active ingredients, purpose, uses, warnings, do not, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol 2.00%
Purpose
Topical Analgesic
Uses
- For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
Warnings
For external use only
Do Not
- apply to wounds or damaged skin.
- bandage tightly.
When Using This Product
- Avoid contact with the eyes.
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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before 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: consult a doctor.
Other Information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1 (CI 42090), Camphor, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Water(Aqua)
Questions?
888-211-8468
Package Labeling:
Label (Label)
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