FDA Label for Swimmers Ear Relief Ear Drops
View Indications, Usage & Precautions
Swimmers Ear Relief Ear Drops Product Label
The following document was submitted to the FDA by the labeler of this product Similasan Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Pulsatilla 12X
Graphites 12X
Sulphur 12X
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
Similasan
Swimmer’s Ear Relief
Ear Drops
10 ml/ 0.33 fl oz
* Please review the disclaimer below.