Active Ingredient
Causticum 12X
Lachesis 12X
Lycopodium 12X
Ear Wax Relief Solution
FDA Label NDC 59262-272
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 Ear Wax Relief (NDC 59262-272). 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, active ingredients, uses:, warnings:, do not use:, if pregnant or breast feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
itching, wax build-up
dryness, wax build-up
dryness, wax build-up
wax build-up
Active Ingredients
Graphites 15X
Uses:
For occasional use as an aid to soften, loosen, and remove excess ear wax. According to homeopathic principles, the ingredients in this medication also provide temporary relief from symptoms such as:
- clogged sensation when caused by ear wax
- ringing in the ear when caused by ear wax
- dry skin and itching of the ear canal
Warnings:
- Initial exacerbation of symptoms may occur.
- Avoid contact with eyes.
Do Not Use:
- if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor
- if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
- for more than 3 days; if excessive ear wax remains after the use of this product, consult a doctor
- with ear tubes
If 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.
Directions:
FOR USE IN THE EAR ONLY.
For adults and children, over 12 years of age:
- remove tamper evident seal from neck of bottle
- twist cap off bottle
- tilt head sideways, squeeze plastic applicator to release 2-3 drops into ear. (Tip of applicator should not enter ear canal.)
- keep drops in ear for several minutes by keeping head tilted or placing cotton in ear
- use twice daily for up to 3 days if needed, or as directed by a doctor
- any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft, rubber bulb ear syringe
- children under 12 years of age: consult 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
Principle Display Panel
NDC 59262-272-11
Similasan
Ear Wax Relief
EAR DROPS
10 ml / 0.33 fl oz
* Please review the disclaimer below.
