TMJ EASE- baptisia tinctoria, calcarea fluorica, causticum, hepar sulphuris calcareum, hypericum perforatum, ignatia amara, kalmia latifolia, nux vomica, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis, symphytum officinale spray

TMJ Ease by

Drug Labeling and Warnings

TMJ Ease by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Relieves jaw pain, inflammation and tension

ACTIVE INGREDIENT

Drug Facts
Active Ingredients: Equal volumes of each ingredient in 10X, 30X, LM1 potencies: Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale

INDICATIONS & USAGE

Uses: For temporary relief of: facial pains of the jaw, facial neuralgia, rigid jaw muscles, inflammations in the jaw, clenching of the jaw, cracking sounds

WARNINGS

Warnings: Stop use and ask a doctor if symptoms persist or worsen

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adults: 3 pumps sprays. Children 2-12: 2 pump sprays

INACTIVE INGREDIENT

Inactive Ingredients: Citric acid, potassium sorbate, pure water

INFORMATION FOR PATIENTS

The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: 1.561.999.8857

No gluten, artificial flavors, animal products, or colorants added

STORAGE AND HANDLING

Tamper resistant for your protection. Use only if safety seal is intact

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TMJ EASE 
baptisia tinctoria, calcarea fluorica, causticum, hepar sulphuris calcareum, hypericum perforatum, ignatia amara, kalmia latifolia, nux vomica, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis, symphytum officinale spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	10 [hp_X]  in 59 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	10 [hp_X]  in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X]  in 59 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	10 [hp_X]  in 59 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	10   in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X]  in 59 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	10 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 59 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	10 [hp_X]  in 59 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-104-59	59 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/27/2013

Labeler - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-104) , api manufacture(68703-104)