TINNITUS CONTROL: Homeopathic Product Information

TINNITUS CONTROL- arnica montana, quinine sulfate, iron, potassium phosphate, dibasic, sodium sulfate, pulsatilla vulgaris, silicon dioxide and allylthiourea liquid
Pacific Naturals

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.

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

TINNITUS CONTROL
(click image for full-size original)

TINNITUS CONTROL
not applicable liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43695-0009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 30 [hp_X] in 1 mL
QUININE SULFATE (QUININE) QUININE SULFATE 30 [hp_X] in 1 mL
IRON (IRON) IRON 30 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) POTASSIUM PHOSPHATE, DIBASIC 30 [hp_X] in 1 mL
SODIUM SULFATE (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE 30 [hp_X] in 1 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 30 [hp_X] in 1 mL
SILICON DIOXIDE (COLLOIDAL SILICON DIOXIDE) SILICON DIOXIDE 30 [hp_X] in 1 mL
ALLYLTHIOUREA (ALLYLTHIOUREA) ALLYLTHIOUREA 30 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43695-0009-1 30 mL in 1 BOTTLE, SPRAY None
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 Operations
Apotheca Company 844330915 manufacture (43695-0009), api manufacture (43695-0009), label (43695-0009), pack (43695-0009)

Revised: 10/2014 Pacific Naturals

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