EAR RINGING SYMPTOM FORMULA- arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coffea tosta, kali iodatum, kalmia latifolia, magnesia carbonica, manganum aceticum, manganum carbonicum, mercurius vivus, natrum salicylicum, salicylicum acidum, thiosinaminum, thyroidinum liquid

Ear Ringing Symptom Formula by

Drug Labeling and Warnings

Ear Ringing Symptom 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

____________________________________________________________________________________________________________

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

HPUS active ingredients: Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.

INDICATIONS & USAGE

Uses for symptomic relief of ear sounds:

• buzzing, roaring, ringing, and whistling
• sensitivity to noise

WARNINGS

Warnings

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

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.
• Adults: 3 sprays 3 times per day.
• Children 6-12 years: 2 sprays 3 times per day.
• Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

• Tamper resistant for your protection. Use only if safety seal is intact.
• This product is intended to complement, not replace, standard medical care.

INACTIVE INGREDIENT

Inactive Ingredients: Bio-Energetically Enhanced pure water, citric acid and potassium sorbate.

PURPOSE

Drug Facts __________________________________________________________________________________________________________________ HPUS active ingredients                                                                    Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arnica montana.....................................................................noise in ear

Calcarea carbonica.................................................................humming in ear

Chenopodium anthelminticum..................................................vertigo

Chininum salicylicum..............................................................tinnitus

Cimicifuga racemosa...............................................................sensitivity to noise

Coffea tosta...........................................................................sensitivity to sound

Kali iodatum..........................................................................noises in ear

Kalmia latifolia.......................................................................vertigo

Magnesia carbonica.................................................................tinnitus

Manganum aceticum...............................................................whistling in ear

Manganum carbonicum...........................................................buzzing and rumbling in ears

Mercurius vivus......................................................................ringing in ears

Natrum salicylicum.................................................................noises in ears

Salicylicum acidum.................................................................roaring and ringing in ears

Thiosinaminum......................................................................tinnitus

Thyroidinum..........................................................................vertigo

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EAR RINGING SYMPTOM FORMULA 
arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coffea tosta, kali iodatum, kalmia latifolia, magnesia carbonica, manganum aceticum, manganum carbonicum, mercurius vivus, natrum salicylicum, salicylicum acidum, thiosinaminum, thyroidinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-7295
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	10 [hp_X]  in 29.6 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 29.6 mL
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I)	DYSPHANIA AMBROSIOIDES	10 [hp_X]  in 29.6 mL
QUININE SALICYLATE (UNII: 6DY04L71DR) (SALICYLIC ACID - UNII:O414PZ4LPZ)	QUININE SALICYLATE	10 [hp_X]  in 29.6 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X]  in 29.6 mL
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E)	COFFEA ARABICA SEED, ROASTED	10 [hp_X]  in 29.6 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	10 [hp_X]  in 29.6 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	10 [hp_X]  in 29.6 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	10 [hp_X]  in 29.6 mL
MANGANESE ACETATE TETRAHYDRATE (UNII: 9TO51D176N) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE ACETATE TETRAHYDRATE	10 [hp_X]  in 29.6 mL
MANGANESE CARBONATE (UNII: 9ZV57512ZM) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CATION (2+)	10 [hp_X]  in 29.6 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	10 [hp_X]  in 29.6 mL
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SODIUM SALICYLATE	10 [hp_X]  in 29.6 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 [hp_X]  in 29.6 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	10 [hp_X]  in 29.6 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	10 [hp_X]  in 29.6 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-7295-2	1 in 1 CARTON
1		29.6 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/09/2013

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	api manufacture(57955-7295)