FDA.reportPublic FDA data

Premiere Value Ear Drops for Swimmers

Manufacturer
Pharmacy Value Alliance; LLC | Pharma Nobis, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:12

Label at a glance#

ProductPremiere Value Ear Drops for Swimmers
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

Apply 5 to 5 drops in each affected ear..

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CVS Ear Drops for Swimmers

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 95% in anhydrous glycerin

Purpose

OTC - PURPOSE SECTION

Ear drying aid

Use

INDICATIONS & USAGE SECTION

Dries water in the ears.

Warnings

WARNINGS SECTION

Flammable: Keep away from fire and flame.

Do not use

OTC - DO NOT USE SECTION

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 doctor if

OTC - STOP USE SECTION

Irritation (too much burning) or pain occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately. 

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 5 to 5 drops in each affected ear..

Other information

OTHER SAFETY INFORMATION

Store at room temperature.

Keep tightly closed.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Glycerin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PV Ear Drops for Swimmers.jpgPV Ear Drops for Swimmers.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN3
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD3
631799isopropyl alcohol 94.998 % Otic SolutionSY3
631799isopropyl alcohol 95 % Otic SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-820-91Premiere Value Ear Drops for Swimmers30 mL in 1 CONTAINERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-820PREMIERE VALUE EAR DROPS FOR SWIMMERS (ISOPROPYL ALCOHOL) LIQUID [PHARMACY VALUE ALLIANCE; LLC]3Current NDC, Legacy NDC, 1 package rows20231221_9d606fe6-ae57-724f-e053-2a95a90abffe.zip

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
68016-82068016-820-91

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
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

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
Premiere Value Ear Drops for SwimmersISOPROPYL ALCOHOLPharmacy Value Alliance; LLC9d606fe6-ae57-724f-e053-2a95a90abffe2023-12-20WarningsExact identifier
ndc (package): 68016-820-91
ndc (product): 68016-820
ndc11 (package): 68016082091
spl id: 0cf4f695-fe54-55e5-e063-6294a90abe00
spl set id: 9d606fe6-ae57-724f-e053-2a95a90abffe

Reported adverse events (FAERS/openFDA)#

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