Otc - Active Ingredient
Carbamide Peroxide 6.5% non USP*
*pH differs from USP specifications
Leader Earwax Removal Kit
FDA Label NDC 70000-0490
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Earwax Removal Kit (NDC 70000-0490). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, inactive ingredient, dosage & administration, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Label (Label)
* Please review the disclaimer below.
