FDA Label for Kids Earache Relief
View Indications, Usage & Precautions
Kids Earache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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
Chamomilla 10X
Mercurius solubilis 15X
Pulsatilla 12X
Sulphur 12X
Purpose
sensitivity to drafts, soothing
fullness, sensitivity to cold
night time calmative
itchiness, sensitivity to water
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as:
• sensation of fullness of the ear
• sensitivity to water and drafts
• the annoyance of water-clogged ears by helping clear water trapped in the ear
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 The Child Has:
• ear drainage or discharge• pain, irritation, or rash in the ear• had ear surgery• dizziness
Directions
FOR USE IN THE EAR ONLY.For children ages 2 and over:
• Remove tamper-evident seal from neck of bottle.
• Twist cap off bottle.
• Tilt child’s head sideways.
• DON'T squeeze bottle, squeeze plastic tip to release 4-5 drops into ear (tip of applicator should not enter ear canal).
• Keep drops in ear for 3-5 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.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredient
Vegetable glycerin
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]
www.SimilasanUSA.com
Principal Display Panel
NDC 59262-276-11
Similasan®
Kids
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz
* Please review the disclaimer below.