Active Ingredients
Pulsatilla 12X
Graphites 12X
Sulphur 12X
Swimmers Ear Relief
FDA Label NDC 59262-278
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 Swimmers Ear Relief (NDC 59262-278). 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
Purpose
pain in ears, humming
blocked sensation in ears
itchiness, sensitivity to water
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve swimmer’s ear symptoms such as:
• pain in ears, humming
• blocked sensation in ears
• itchiness, sensitivity to water
Warnings
• Do not use in the eyes.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)
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.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredient
Purified water, Vegetable glycerin
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]
www.SimilasanUSA.com
Principal Display Panel
NDC 59262-278-11
Similasan
Swimmer’s Ear Relief
Ear Drops
10 ml/ 0.33 fl oz
Principal Display Panelndc 59262-278-11similasanswimmer’s Ear Reliefear Drops10 mL/ 0.33 Fl Oz (Swimmers Ear Relief 01)
Principal Display Panelndc 59262-278-11similasanswimmer’s Ear Reliefear Drops10 mL/ 0.33 Fl Oz (Swimmers Ear Relief 02)
* Please review the disclaimer below.
