Ear Ringing Remedy
FDA Label NDC 53799-275

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Similasan Ag for the product Ear Ringing Remedy (NDC 53799-275). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses*, warnings, keep out of reach of children., stop use and ask a doctor if:, ask a doctor before use if you have:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses*

→ Warnings

→ Keep Out Of Reach Of Children.

→ Stop Use And Ask A Doctor If:

→ Ask A Doctor Before Use If You Have:

→ Directions

→ Other Information

→ Inactive Ingredient

→ Questions?

→ Principal Display Panel

Active Ingredients

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

Purpose

buzzing
ringing, humming
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

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with ear discomfort due to:

• 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.

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 3 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.