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

TMJ / Jaw Formula by

Drug Labeling and Warnings

TMJ / Jaw Formula by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts​__________________________________________________________________________________________________________

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

INDICATIONS & USAGE

Uses ​for temporary relief of: facial pains of the jaw, facial neuralgia, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.​

INACTIVE INGREDIENT

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS

Warnings

• Stop use and ask your doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, ask a healthcare professional before ues.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Ages 12 and up: 3 sprays 3 times per day.
• Ages 2-12: 2 sprays 3 times per day

OTHER SAFETY INFORMATION

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

PURPOSE

Uses ​for temporary relief of:

• facial pains of the jaw
• facial neuralgia
• rigid jaw muscles
• inflammation in the jaw
• clenching of the jaw
• cracking sounds

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-5032
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 [hp_X]  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
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-5032-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/18/2016

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-5032)