Fibrocane Relief
FDA Label NDC 57850-2000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Bioceuticals Llc for the product Fibrocane Relief (NDC 57850-2000). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients:

Symphytum officinale 3X, Capsicum annuum 6X, Ledum palustre 6X, Colchicum autumnale 12X, Rhododendron chrysanthum 12X, Ruta graveolens 12X.

Indications:

For temporary relief of minor symptoms of joint pain and inflammation.*

*These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

For temporary relief of minor symptoms of joint pain and inflammation.*

*These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

Warnings:

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

When using this product do not get into eyes.

Stop use and call a doctor if condition worsens or symptoms last more than 7 days.

Consult a physician for use in children under 12 years of age.

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.

Directions:

Apply generously and rub thoroughly for 20-30 seconds over the affected area.  Flexing and releasing the affected muscles and joints after applying this product may enhance its ability to help you.  This process may be repeated several times a day.

Inactive Ingredients:

Acrylates/C10-30 alkyl acrylate crosspolymer, Aloe barbadensis leaf juice, Arnica (flower), Ascorbic acid, Celery (seed), Comfrey leaf, Devil's Claw (root), Edate disodium (EDTA), Feverfew (leaf), Vitamin E, Oregano, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly glycol, Sorbic acid, Poke (root), Potassium sorbate, Purified Water, Sodium hydroxide, Turmeric (root), White willow (bark)

Questions:

Distributed by Premier Bioceuticals LLC,

P. O. BOX 78391

Indianapolis, IN 46278

Package Label Display:

Premier BIOCEUTICALS

NDC 57850-2000-1

FibroCane

RELIEF

For temporary relief of monor symptoms of joint pain and inflammation.

Homeopathic Gel

paraben-free

Ner wt. 2 oz.  (57 g)

* Please review the disclaimer below.