Fibro Flex
FDA Label NDC 61495-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Magnesium Direct Inc. for the product Fibro Flex (NDC 61495-401). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Magnesia Muriatica 1X HPUS
Purpose
Joint and soft tissue pain
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Uses Temporarily relieves the symptoms of Fibromyalgia pain.
Warnings
Warnings FOR EXTERNAL USE ONLY
If pregnant or breast feeding, ask a health professional before use. Consult a physician if symptoms persist for more than 7 days or worsen. Stop use if: Excessive irritation or burning of skin develops.
Dosage & Administration
Directions Apply 4-8 sprays to areas with Fibromyalgia pain on the body. Rub thoroughly. For convenience, spray into hand first, then apply. May be used multiple times daily. DO NOT use more than 100 sprays in a 24 hour period.
Inactive Ingredient
Inactive Ingredients: water, calcium chloride, trace minerals.
Otc - Questions
Questions? 1-888-249-8574 M-F, 9-5, EST
Distributed by: Magnesium Direct
Alpharetta, GA 30005
WWW. FIBRO-FLEX.COM
* Please review the disclaimer below.
