TINNITUS CONTROL- not applicable liquid

TINNITUS CONTROL by

Drug Labeling and Warnings

TINNITUS CONTROL by is a Homeopathic medication manufactured, distributed, or labeled by Pacific Naturals, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

ARNICA MONTANA 30X,  CHININUM SULPHURICUM 30X,  FERRUM METALLICUM 30X,  KALI PHOSPHORICUM 30X,  NATRUM SULPHURICUM 30X,  PULSATILLA (VULGARIS) 30X,  SILICEA 30X,  THIOSINAMINUM 30X

INDICATIONS:

Helps relieve symptoms of Tinnitus.

WARNINGS:

If pregnant or breast-feeding, seek the advice of a doctor before use. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and Children over 12: Spray twice under the tongue 3 times per day.

Children under 12: Consult a doctor prior to use.

INDICATIONS:

Helps relieve symptoms of Tinnitus.

INACTIVE INGREDIENTS:

Alcohol 20% v/v, Purified water.

QUESTIONS:

Distributed by:

Pacific Naturals

PO Box 7574

Milton Keynes

MK11 9GQ, United Kingdom

PACKAGE LABEL DISPLAY:

Tinnitus

Control

Helps relieve the

symptoms of Tinnitus

HOMEOPATHIC

1.0 fl. oz. (30 ml), 20% alcohol

INGREDIENTS AND APPEARANCE

TINNITUS CONTROL 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43695-0009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)	QUININE SULFATE	30 [hp_X]  in 1 mL
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	30 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	30 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	30 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X]  in 1 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43695-0009-1	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/14/2014

Labeler - Pacific Naturals (184784283)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43695-0009) , api manufacture(43695-0009) , label(43695-0009) , pack(43695-0009)