Active Ingredient
Isopropyl alcohol, 95%
Swim-ear Solution
FDA Label NDC 0168-0126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fougera Pharmaceuticals, Llc for the product Swim-ear (NDC 0168-0126). 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 active ingredient, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Ear drying aid
Uses
Dries water in the ears and relieves water-clogged ears after:
- swimming
- showering
- bathing
- washing the hair.
Warnings
Flammable: Keep away from fire or flame.
Otc - Do Not Use
Do not use in the eyes.
Otc - Ask Doctor
Ask a doctor before use if you have
- ear drainage or discharge
- pain, irritation or rash in ear
- had ear surgery
- dizziness
Otc - When Using
Otc - Stop Use
Stop use and ask a doctor if irritation (too much burning) or pain occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Apply 4 to 5 drops in each affected ear.
Inactive Ingredient
Inactive ingredient
Anhydrous glycerin 5% base.
Other
E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747
IP4808C
R10/12
#8
Package Label – Principal Display Panel – 1 Oz Container
NDC 0168-0126-91
Swim-EAR®
EAR DRYING AID
29.57 mL (1 fl oz)
Package Label – Principal Display Panel – 1/2 Oz Container (Swimear1)
Package Label – Principal Display Panel – 1 Oz Carton
NDC 0168-0126-91
Swim-EAR®
EAR DRYING AID
29.57 mL (1 fl oz)
Package Label – Principal Display Panel – 1/32 Oz Container (Swimear2)
* Please review the disclaimer below.
