TINNITUS RELIEF- arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coff

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I), DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I), QUININE SALICYLATE (UNII: 6DY04L71DR) (SALICYLIC ACID - UNII:O414PZ4LPZ), BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9), COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E),
Available from:
King Bio Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses for temporary relief of symptoms: intermittent, continuous or pulsating ear sounds (buzzing, hissing, and whistling), acute sensitivity to sounds, hearing loss. Uses  ​for temporary relief of symptoms: - intermittent, continuous or pulsating ear sounds (buzzing, hissing, and whistling) - acute sensitivity to sounds - hearing loss.
Authorization status:
unapproved homeopathic
Authorization number:
57955-0275-2

TINNITUS RELIEF- 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

King Bio Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Tinnitus Relief™

Drug Facts

__________________________________________________________________________________________________________

HPUS active ingredients:

Arnica montana, Calcarea carbonica, Chenopodium anthelminticum,

Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia

carbonica, Manganum acxeticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum,

Salicylicum acidum, Thiosinaminum, Thyroidinum. Equal volumes of each ingredient in 10X, 30X,

100X, 1M, LM1, LM2, LM3 potencies.

Uses for temporary relief of symptoms: intermittent, continuous or pulsating ear sounds (buzzing,

hissing, and whistling), acute sensitivity to sounds, hearing loss.

Inactive Ingredients:

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

Warnings

Stop use and ask your doctor if symptoms persist or worsen.

If pregnant or breast-feeding, take only on advice of a healthcare professional.

Keep out of reach of children.

Directions

Initially, depress pump until primed.

Spray one dose directly into mouth.

Adults 12 and up: 3 sprays 3 times per day

Children 2-12: 2 sprays 3 times per day

Children 2mo-2yr.: 1 spray 3 times per day

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been

clinically tested.

Uses

for temporary relief of symptoms:

intermittent, continuous or pulsating ear sounds (buzzing, hissing, and whistling)

acute sensitivity to sounds

hearing loss.

TINNITUS RELIEF

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:579 55-0 275

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

10 [hp_X]

in 59 mL

O YSTER SHELL CALCIUM CARBO NATE, CRUDE (UNII: 2E328 21G6 I) (OYSTER

SHELL CALCIUM CARBONATE, CRUDE - UNII:2E328 21G6 I)

OYSTER SHELL CALCIUM

CARBONATE, CRUDE

10 [hp_X]

in 59 mL

DYSPHANIA AMBRO SIO IDES (UNII: 4H5RSU0 8 7I) (CHENOPODIUM AMBROSIOIDES -

UNII:4H5RSU0 8 7I)

DYSPHANIA AMBROSIOIDES

10 [hp_X]

in 59 mL

Q UININE SALICYLATE (UNII: 6 DY0 4L71DR) (SALICYLIC ACID - UNII:O414PZ4LPZ)

QUININE SALICYLATE

10 [hp_X]

in 59 mL

BLACK CO HO SH (UNII: K73E24S6 X9 ) (BLACK COHOSH - UNII:K73E24S6 X9 )

BLACK COHOSH

10 [hp_X]

in 59 mL

CO FFEA ARABICA SEED, RO ASTED (UNII: 9 H58 JRT35E) (COFFEA ARABICA SEED,

ROASTED - UNII:9 H58 JRT35E)

COFFEA ARABICA SEED,

ROASTED

10 [hp_X]

in 59 mL

PO TASSIUM IO DIDE (UNII: 1C4QK22F9 J) (IODIDE ION - UNII:0 9 G4I6 V8 6 Q)

IODIDE ION

10 [hp_X]

in 59 mL

KALMIA LATIFO LIA LEAF (UNII: 79 N6 542N18 ) (KALMIA LATIFOLIA LEAF -

UNII:79 N6 542N18 )

KALMIA LATIFOLIA LEAF

10 [hp_X]

in 59 mL

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA) (CARBONATE ION -

UNII:7UJQ5OPE7D)

MAGNESIUM CARBONATE

10 [hp_X]

in 59 mL

MANGANESE ACETATE TETRAHYDRATE (UNII: 9 TO51D176 N) (MANGANESE

CATION (2+) - UNII:H6 EP7W5457)

MANGANESE ACETATE

TETRAHYDRATE

10 [hp_X]

in 59 mL

MANGANESE CARBO NATE (UNII: 9 ZV57512ZM) (MANGANESE CATION (2+) -

UNII:H6 EP7W5457)

MANGANESE CATION (2+)

10 [hp_X]

in 59 mL

MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)

MERCURY

10 [hp_X]

in 59 mL

SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SODIUM SALICYLATE

10 [hp_X]

in 59 mL

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

10 [hp_X]

in 59 mL

ALLYLTHIO UREA (UNII: 70 6 IDJ14B7) (ALLYLTHIOUREA - UNII:70 6 IDJ14B7)

ALLYLTHIOUREA

10 [hp_X]

in 59 mL

THYRO ID, UNSPECIFIED (UNII: 0 B4FDL9 I6 P) (THYROID, UNSPECIFIED -

UNII:0 B4FDL9 I6 P)

THYROID, UNSPECIFIED

10 [hp_X]

in 59 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:579 55-0 275-2

59 mL in 1 BOTTLE, SPRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

11/0 6 /20 12

King Bio Inc.

Labeler -

King Bio Inc. (617901350)

Registrant -

King Bio Inc. (617901350)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

King Bio Inc.

6 179 0 1350

ma nufa c ture (579 55-0 275)

Revised: 3/2015

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