FDA Label for Suavear Earwax Removal Aid
View Indications, Usage & Precautions
Suavear Earwax Removal Aid Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals Inc. 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 Ingredient
Carbamide Peroxide 6.5%
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.