Active Ingredient
Carbamide Peroxide 6.5%
Suavear Earwax Removal Aid Solution/ Drops
FDA Label NDC 13709-312
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Suavear Earwax Removal Aid (NDC 13709-312). 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, when using this product, stop use and ask a doctor if, keep this and all drugs out of the 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
Earwax Removal Aid
Uses
For occasional use as an aid to soften, loosen and remove excessive earwax
Warnings
Ask a doctor before use if you have
- Ear drainage or discharge
- Ear Pain
- Irritation or rash in the ear
- Dizziness
- An injury or perforation (hole) of the eardrum
- Recently had ear surgery
When Using This Product
Avoid contact with the eyes
Stop Use And Ask A Doctor If
- You need to use for more than 3 days in a row
Keep This And All Drugs Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
FOR USE IN THE EAR ONLY
Adults and children 12 years of age:
- Tilt head sideways
- Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal
- Keep drops in the ear for sevaral minutes, either by using teh included earplugs or keeping the head tilted to the side
- Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb
- Use twice daily for upto four days, or as directed by a doctor
Children under 12 years: consult a doctor
Other Information
- Store bottle in the outer carton
- Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound.
- Keep cap on bottle when not in use
Inactive Ingredients
Glycerin
Oxyquinoline
* Please review the disclaimer below.
