Ear Ringing Remedy
FDA Label NDC 59262-275

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 Corporation for the product Ear Ringing Remedy (NDC 59262-275). 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

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 [email protected]

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

Ndc 59262-275-11similasanear Ringing Remedy 10 mL/ 0.33 Fl Oz (Ear Ringing Remedy 01)

Ndc 59262-275-11similasanear Ringing Remedy 10 mL/ 0.33 Fl Oz (Ear Ringing Remedy 01)

* Please review the disclaimer below.