Otc - Active Ingredient
Isopropyl Alcohol 95% in 5% Anhydrous Glycerin
Freskaro Ear Drops For Swimmers Liquid
FDA Label NDC 82645-098
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 Ear Drops For Swimmers (NDC 82645-098). 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, inactive ingredients, otc - purpose, indications & usage, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Glycerin
Otc - Purpose
Ear Drying Aid
Indications & Usage
Dries water in the ears
Warnings
Flammable: Keep away from fire or flame
Do not use in the eyes
Ask A Doctor Before Use If You Have
- ear drainage or discharge
- pain, irritation, or rash in the ear
- have had ear surgery
- dizziness
Stop Use And Ask A Doctor If
- irritation (too much burning) or pain occurs.
If Pregnant Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Dosage & Administration
Apply 4 to 5 drops in each affected ear
Other Safety Information
Store at room temperature
keep tightly closed
* Please review the disclaimer below.
