FDA Label for Earwax Removal Drops
View Indications, Usage & Precautions
Earwax Removal Drops Product Label
The following document was submitted to the FDA by the labeler of this product Randob Labs, Ltd.. 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.
Dosage & Administration
FOR USE IN THE EAR ONLY
Adults & Children over 12 yrs of age:
Tilt head to the side and place 5-10 drops into ear.
Dropper tip of removal drops should not enter ear canal.
Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
Use twice daily for up to four days if needed, or as directed by a doctor.
Safely scoop out wax with removal tool.
Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.
Children under 12 yrs of age:
Consult a doctor.
Indications & Usage
For occasional use as an aid to soften, loosen and remove excessive earwax.
Otc - Purpose
Earwax Removal Aid
Otc - Active Ingredient
Carbamide Peroxide 6.5%
Inactive Ingredient
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if:
you need to use more than four days
excessive earwax remains after use of this product
Other Safety Information
Other Information
Do not use if neck wrap imprinted safety seal is broken or missing
Do not store above 25 degrees C, 77 degrees F
Store bottle in outer carton
Keep cap on bottle when not in use
Product foams on contacy with earwax due to release of oxygen
Warnings
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
* Please review the disclaimer below.