Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3f6db893-fd40-4f01-a869-96923322b7f7
Route
TOPICAL
Published
Effective Date 2014-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Comfrey Root (3 [hp_X]) Capsicum (6 [hp_X]) Ledum Palustre Twig (12 [hp_X]) Colchicum Autumnale Bulb Rhododendron Aureum Leaf Ruta Graveolens Flowering Top
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-06-17

Description

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


Medication Information

Description

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

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.

Questions:

Distributed by Premier Bioceuticals LLC,

P. O. BOX 78391

Indianapolis, IN 46278

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.

Active Ingredients:

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

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)

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)

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.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by Premier Bioceuticals LLC,

P. O. BOX 78391

Indianapolis, IN 46278

Directions: (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: (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.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (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)

Package Label Display: (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)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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