FIBROCANE RELIEF- symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gel

Fibrocane Relief by

Drug Labeling and Warnings

Fibrocane Relief by is a Homeopathic medication manufactured, distributed, or labeled by Premier Bioceuticals LLC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 g
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	12 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	12 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CELERY SEED (UNII: 1G1EAA320L)
COMFREY LEAF (UNII: DG4F8T839X)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FEVERFEW (UNII: Z64FK7P217)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TURMERIC (UNII: 856YO1Z64F)
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57850-2000-1	57 g in 1 TUBE

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	Business Operations
Apotheca Company		844330915	manufacture(57850-2000) , api manufacture(57850-2000) , label(57850-2000) , pack(57850-2000)