drug facts

drug facts
SPL v1
SPL
SPL Set ID eee2d5bf-f085-4c88-902d-5ac3b050f7ae
Route
topical
Published
Effective Date 2013-04-23
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
aloe vera leaf arnica montana flower carbomer interpolymer type a (allyl sucrose crosslinked) celery seed comfrey leaf harpagophytum procumbens root edetate disodium feverfew oregano polyethylene glycol 1500 peg-8 dimethicone polyethylene glycol 700 phenoxyethanol caprylyl glycol sorbic acid phytolacca americana root potassium sorbate water sodium hydroxide turmeric ascorbic acid tocopherol salix alba bark

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2013-04-22

Indications and Usage

For temporary relief of minor pain and inflammation.

Description

Symphytum Officinale 3X, Capsicum Annuum 6X, Ledum Palustre 6X, Colchicum Autumnale 12X, Rhododendron Chrysanthum 12X, Ruta Graveolens 12X


Medication Information

Warnings

For topical use only.  If pregnant or breast-feeding, consult a health professional before use.  Keep out of the reach of children.  If swallowed, seek medical help or consult a Poison Control Center immediately.  Do not get into eyes.  Stop use and consult a physician if condition worsens or symptoms last more than 7 days.  Tube contains tamper-evident seal under cap.  Do not use if seal is missing or broken. 

Indications and Usage

For temporary relief of minor pain and inflammation.

Directions

Apply gel up to 3 times daily onto the affected area.  Consult physician for use by children under 12 years of age. 

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Arnica Montana (Flower), Acrylates C10-30 Alkyl Acrylate Crosspolymer, Celery (seed), Comfrey (leaf), Devil's Claw (root), Edetate Disodium, Feverfew (leaf), Natural plant extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Poke (root), Potassium sorbate, Purified Water, Sodium Hydroxide, Tumeric (root), Ascorbic Acid, Mixed Tocopherols, Salix Alba (bark)

Description

Symphytum Officinale 3X, Capsicum Annuum 6X, Ledum Palustre 6X, Colchicum Autumnale 12X, Rhododendron Chrysanthum 12X, Ruta Graveolens 12X

Section 51945-4

NATURX

Anti-Inflammatory

Pain Relief

GEL

Homeopathic

NATURAL

paraben-free

Net wt. 3.7 oz. (105 g)

Questions

DRSONLYLAB LLC

14 Shadow Tree Lane

Briarcliff Manor, NY  10510

(877) 680-8390

www.DrsOnlyLab.com

Indications

For temporary relief of minor pain and inflammation. 

Active Ingredients

Symphytum Officinale 3X, Capsicum Annuum 6X, Ledum Palustre 6X, Colchicum Autumnale 12X, Rhododendron Chrysanthum 12X, Ruta Graveolens 12X

Keep Out of Reach of Children

If swallowed, seek medical help or consult a Poison Control Center immediately.


Structured Label Content

Warnings (WARNINGS)

For topical use only.  If pregnant or breast-feeding, consult a health professional before use.  Keep out of the reach of children.  If swallowed, seek medical help or consult a Poison Control Center immediately.  Do not get into eyes.  Stop use and consult a physician if condition worsens or symptoms last more than 7 days.  Tube contains tamper-evident seal under cap.  Do not use if seal is missing or broken. 

Indications and Usage (INDICATIONS AND USAGE)

For temporary relief of minor pain and inflammation.

Directions (DIRECTIONS)

Apply gel up to 3 times daily onto the affected area.  Consult physician for use by children under 12 years of age. 

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Barbadensis Leaf Juice, Arnica Montana (Flower), Acrylates C10-30 Alkyl Acrylate Crosspolymer, Celery (seed), Comfrey (leaf), Devil's Claw (root), Edetate Disodium, Feverfew (leaf), Natural plant extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Poke (root), Potassium sorbate, Purified Water, Sodium Hydroxide, Tumeric (root), Ascorbic Acid, Mixed Tocopherols, Salix Alba (bark)

Section 51945-4 (51945-4)

NATURX

Anti-Inflammatory

Pain Relief

GEL

Homeopathic

NATURAL

paraben-free

Net wt. 3.7 oz. (105 g)

Questions (QUESTIONS)

DRSONLYLAB LLC

14 Shadow Tree Lane

Briarcliff Manor, NY  10510

(877) 680-8390

www.DrsOnlyLab.com

Indications (INDICATIONS)

For temporary relief of minor pain and inflammation. 

Active Ingredients (ACTIVE INGREDIENTS)

Symphytum Officinale 3X, Capsicum Annuum 6X, Ledum Palustre 6X, Colchicum Autumnale 12X, Rhododendron Chrysanthum 12X, Ruta Graveolens 12X

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, seek medical help or consult a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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