FDA Label for Leader Earwax Removal Kit
View Indications, Usage & Precautions
Leader Earwax Removal Kit Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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.
Otc - Active Ingredient
Carbamide Peroxide 6.5% non USP*
*pH differs from USP specifications
Otc - Purpose
Earwax removal aid
Indications & Usage
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 ear
recently had ear surgery
dizziness
an injury or perforation of the eardrum
Inactive Ingredient
Citric acid
Flavor
Glyrcerin
Propylene glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Purified water
Dosage & Administration
- tilt head sideways
- palce 5 to 10 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 the ear
- use twice daily for up to four days if needed, or as directed by a doctor
- any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Posion Control Center right away.
Package Label.Principal Display Panel
* Please review the disclaimer below.