Drug Facts: Active Ingredient
Isopropyl alcohol 95% in an anhydrous glycerin 5% base
Swimmers Ear Solution/ Drops
FDA Label NDC 13709-347
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Swimmers Ear (NDC 13709-347). 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 drug facts: active ingredient, purpose, use:, warnings: flammable:, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep this and all drugs out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Ear drying aid
Use:
- Dries water in the ears after swimming, bathing, showering, or other water-based activities.
Warnings: Flammable:
Keep away from flame or fire
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
Keep This And All Drugs Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions:
- Apply 4 to 5 drops in each affected ear.
Other Information:
- Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41°F to 131°F (5°C to 55°C) during transportation.
- Recap bottle after each use
- Keep away from heat or direct sunlight
Important:
Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
Inactive Ingredients
Glycerin
* Please review the disclaimer below.
