PHYTOGEL- homeopathic gel gel

PhytoGel by

Drug Labeling and Warnings

PhytoGel by is a Homeopathic medication manufactured, distributed, or labeled by Energetix Corp, Terra Botanica LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Active Ingredients

Arnica montana 1X–0.54%, Calendula officinalis 1X–0.54%, Hypericum perforatum 1X–0.54%, Arnica montana 30C, Bellis perennis 12X, Calcarea fluorica 30X, Ferrum phosphoricum 30X, Hypericum perforatum 30C, Ledum palustre 12X, Natrum sulphuricum 30C, Rhus toxicodendron 30X, Sulphuricum acidum 12X, Symphytum officinale 3X

Warnings Section

If swallowed, get medical help or contact a Poison Control Center right away. For external use only. Do not apply to open wounds.

DO NOT USE

Do not use if seal has been punctured or is not visible.

OVERDOSAGE

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STORAGE AND HANDLING

QUESTIONS

Distributed by Energetix Corp.

209 W. Deerfield Ln.

Dahlonega, GA 30533

800.990.7085

PURPOSE

Topical, homeopathic pain-relief gel.

INACTIVE INGREDIENT

Aloe barbadensis (Aloe Vera Gel), Water, Carbomer, [Potassium Sorbate, Phenoxyethanol (and) Ethylhexylglycerin, Sodium Hydroxide, each at 1% or less].

DOSAGE & ADMINISTRATION

Apply topically three times daily or as directed by a healthcare professional.

INDICATIONS & USAGE

Pain related to sprains, strains, bruises, joints, burns, sunburns, insect bites, skin irritations, and muscles aches.

INGREDIENTS AND APPEARANCE

PHYTOGEL 
homeopathic gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64578-0110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 59.1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	12 [hp_X]  in 59.1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	30 [hp_X]  in 59.1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 59.1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	30 [hp_X]  in 59.1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X]  in 59.1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	12 [hp_X]  in 59.1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	30 [hp_C]  in 59.1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X]  in 59.1 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF)	SULFURIC ACID	12 [hp_X]  in 59.1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 59.1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	7.395801 mL  in 59.1 mL
ALCOHOL (UNII: 3K9958V90M)	1.84895 mL  in 59.1 mL
ALOE (UNII: V5VD430YW9)	46.494 g  in 59.1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64578-0110-1	59.1 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/14/2014

Labeler - Energetix Corp (969572502)

Establishment
Name	Address	ID/FEI	Business Operations
Terra Botanica LLC		963736785	manufacture(64578-0110) , label(64578-0110) , pack(64578-0110)