Fibrocane Relief: Homeopathic Product Information

FIBROCANE RELIEF- comfrey root, capsicum, ledum palustre twig, colchicum autumnale bulb, rhododendron aureum leaf and ruta graveolens flowering top gel
Premier Bioceuticals LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

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.

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.

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)

FibroCane Relief
(click image for full-size original)
FIBROCANE RELIEF
symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57850-2000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 3 [hp_X] in 1 g
CAPSICUM (CAPSICUM) CAPSICUM 6 [hp_X] in 1 g
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 g
COLCHICUM AUTUMNALE BULB (COLCHICUM AUTUMNALE BULB) COLCHICUM AUTUMNALE BULB 12 [hp_X] in 1 g
RHODODENDRON AUREUM LEAF (RHODODENDRON AUREUM LEAF) RHODODENDRON AUREUM LEAF 12 [hp_X] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALOE VERA LEAF
ARNICA MONTANA FLOWER
ASCORBIC ACID
CELERY SEED
COMFREY LEAF
HARPAGOPHYTUM PROCUMBENS ROOT
EDETATE DISODIUM
FEVERFEW
.ALPHA.-TOCOPHEROL
OREGANO
POLYETHYLENE GLYCOL 1500
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 700
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
PHYTOLACCA AMERICANA ROOT
POTASSIUM SORBATE
WATER
SODIUM HYDROXIDE
TURMERIC
SALIX ALBA BARK
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57850-2000-1 57 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/17/2014
Labeler — Premier Bioceuticals LLC (027714978)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (57850-2000), api manufacture (57850-2000), label (57850-2000), pack (57850-2000)

Revised: 06/2014 Premier Bioceuticals LLC

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