Active Ingredient
Chamomilla 10X
Mercurius solubilis 15X
Pulsatilla 12X
Sulphur 12X
Kids Ear Relief
FDA Label NDC 59262-273
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 Kids Ear Relief (NDC 59262-273). 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 ingredient, purpose, uses:, warnings:, ask a doctor before use if the child has:, stop use and ask a doctor if:, keep out of reach of children., directions:, 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:
Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.
Warnings:
- Do not use in the eyes.
- Initial exacerbation of symptoms may occur.
Ask A Doctor Before Use If The Child Has:
- ear drainage or discharge
- pain, irritation, or rash in the ear
- had ear surgery
- dizziness
Stop Use And Ask A Doctor If:
- irritation (too much burning) or pain occurs
- symptoms persist for more than 48 hours
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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.
- Squeeze plastic applicator and apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
- Keep drops in ear by keeping head tilted or placing cotton in 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 us at [email protected]
www.SimilasanUSA.com
Principal Display Panel
NDC 59262-273-11
Similasan
Kids Ear Relief
EAR DROPS
10 ml / 0.33 fl oz
Ndc 59262-273-11 Similasan Kids Ear Relief Ear Drops 10 mL / 0.33 Fl Oz (Kids Ear Relief 1) 
* Please review the disclaimer below.
