EAR RINGING REMEDY- chamomilla and mercurius solubilis and sulphur solution

Ear Ringing Remedy by

Drug Labeling and Warnings

Ear Ringing Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Arnica 15X
Chininum sulphuricum12X
Eriodictyon californicum 12X
Hepar 12X
Lachesis 15X
Lycopodium 12X
Silica15X
Thiosinaminum 15X

Purpose

Buzzing
tinkling, buzzing
ear discomfort, dizziness
pulsations/pounding, buzzing
throbbing, tinkling, roaring, cracking, buzzing, rolling, whizzing, resounding noise in ears
ringing, tinkling, buzzing, roaring, humming, whizzing in the ears
tinkling, clucking, roaring, singing, noises in ear
ringing, chirping

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

ringing       buzzing       roaring

humming       pounding

Warnings

• Do not use in the eyes.
  
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

Stop use and ask a doctor if:

• symptoms persist for more than 48 hours
  
• there is discharge from the ear
  
• there is a fever of 102°F or greater

Ask a doctor before use if you have:

• ear drainage or discharge
  
• pain, irritation, or rash in the ear
  
• had ear surgery
  
• dizziness

Directions

FOR USE IN THE EAR ONLY.

• Remove tamper-evident seal from neck of bottle.
  
• Twist cap off bottle.
  
• Tilt head sideways.
  
• DON'T squeeze bottle, squeeze plastic tip to release 4 to 5 drops into ear (Tip of applicator should not enter ear canal).
  
• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.
  
• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
  
• Children under 12 years of age consult a doctor.

Other information

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

Vegetable glycerin, purified water

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com

www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration

Principal Display Panel

NDC: 59262-275-11
Similasan
Ear Ringing Remedy
10 mL/ 0.33 fl oz

INGREDIENTS AND APPEARANCE

EAR RINGING REMEDY 
chamomilla and mercurius solubilis and sulphur solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-275
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	15 [hp_X]  in 10 mL
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)	QUININE SULFATE	12 [hp_X]  in 10 mL
ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H)	ERIODICTYON CALIFORNICUM LEAF	12 [hp_X]  in 10 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 10 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X]  in 10 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 10 mL
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) (SILICA DIMETHYL SILYLATE - UNII:EU2PSP0G0W)	SILICA DIMETHYL SILYLATE	15 [hp_X]  in 10 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	15 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-275-11	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/01/2018

Labeler - Similasan Corporation (111566530)