Otc - Active Ingredient
Carbamide Peroxide 6.5% non USP*
*pH differs from USP specifications
Freskaro Earwax Removal Aid Liquid
FDA Label NDC 82645-097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Freskaro Earwax Removal Aid (NDC 82645-097). 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, do not use, when using this product, stop use and ask a doctor if, inactive ingredient, dosage & administration, 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.
Do Not Use
- if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor
- if you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor
- for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.
When Using This Product
- avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor.
Stop Use And Ask A Doctor If
- excessive earwax remains after use of this product for 4 consecutive days.
Inactive Ingredient
Citric acid
Flavor
Glycerin
Propylene Glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Purified Water
Dosage & Administration
- FOR USE IN THE EAR ONLY. Remove any hearing aids before use.
- Adults and children over 12 years of age:
- tilt head sideways
- place 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 (body temperature) water, using a soft rubber bulb ear syringe
- Children under 12 years of age: Consult a physician
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Posion Control Center right away.
* Please review the disclaimer below.
