FDA.reportPublic FDA data

Freskaro Ear Drops for Swimmers

Manufacturer
Pharma Nobis, LLC
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:01:59

Label at a glance#

ProductFreskaro Ear Drops for Swimmers
Active ingredientGLYCERIN, ISOPROPYL ALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

OTC - PURPOSE SECTION

Ear Drying Aid

INDICATIONS & USAGE SECTION

Dries water in the ears

WARNINGS SECTION

Flammable: Keep away from fire or flame

Do not use in the eyes

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • ear drainage or discharge
  • pain, irritation, or rash in the ear
  • have had ear surgery
  • dizziness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation (too much burning) or pain occurs.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Apply 4 to 5 drops in each affected ear

OTHER SAFETY INFORMATION

Store at room temperature

keep tightly closed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Ear Drops Swimmer Carton 2026Freskaro Ear Drops Swimmer Carton 2026Freskaro Ear Drops Swimmer Bottle 2026Freskaro Ear Drops Swimmer Bottle 2026

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-09882645-098-91

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-03daily-update2026-06-06 05:10:16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
ndc (package): 82645-098-91
ndc (product): 82645-098
ndc11 (package): 82645009891
spl id: 561bcc22-593f-b0e6-e063-6394a90a55fd
spl set id: 4f724d85-cd38-41da-e063-6394a90a9fd7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.