Active Ingredients
Chamomilla 10X
Mercurius solubilis 15X
Pulsatilla 12X
Sulphur 12X
Childrens Earache Relief
FDA Label NDC 53799-276
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 Childrens Earache Relief (NDC 53799-276). 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, if pregnant, trying to get pregnant or breast feeding,, keep out of reach of children., stop use and ask a doctor if:, ask a doctor before use if the child has:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 cold, drafts, and water
• the annoyance of water-clogged ears by helping clear water trapped in the ear
Warnings
• Do not use in the eyes.
Children under 2 years of age should be seen by a physician.
• 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 3-5 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
Purified water, Vegetable glycerin
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]
www.SimilasanUSA.com
Principal Display Panel
Similasan
Children’s
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz
Similasanchildren’s Earachereliefear Drops10 mL / 0.33 Fl Oz (Childrens Earache Relief 01)
Spanish Label (Childrens Earache Relief 02)
* Please review the disclaimer below.
