FDA.reportPublic FDA data

OIDO SANA

Manufacturer
ProMex LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:42

Label at a glance#

ProductOIDO SANA
Active ingredientISOPROPYL ALCOHOL
Label structure7 sections

Indications and uses

dries water in the ears

Dosage and administration

remove safety seal from bottle, apply 4 to 5 drops in each affected ear.

Storage and handling

Recap bottle after each use Keep away from heat or direct sunlight Store at room temperature Do not use if safety seal is damaged or missing prior to first use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION
Active Ingredients:Purpose
Isopropyl alcohol 95%Ear drying aid
Anhydrous glycerin 5% baseEar drying aid

Uses

INDICATIONS & USAGE SECTION

dries water in the ears

Warnings

WARNINGS SECTION

Flammable: Keep away from fire and flame

Use only in a well ventilated area; fumes may be toxic.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Ear drainage or discharge
  • Pain, irritation or rash in the ear
  • Had ear surgery
  • Dizziness

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation (too much burning) or pain occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

remove safety seal from bottle, apply 4 to 5 drops in each affected ear.

Other information

STORAGE AND HANDLING SECTION

  • Recap bottle after each use
  • Keep away from heat or direct sunlight
  • Store at room temperature
  • Do not use if safety seal is damaged or missing prior to first use

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OIDO® SANA

Pro-Mex®

Fast Relief for

Ears

1 fl oz (30 mL)

Principal Display Panel - 30 mL Bottle Carton
Principal Display Panel - 30 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN5
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD5
631799isopropyl alcohol 94.998 % Otic SolutionSY5
631799isopropyl alcohol 95 % Otic SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58988-1100-12022-01-30C16284748780-1d6a99b39-bb08-a426-e053-dadaa90af4c2OIDO ® SANA
58988-1100-12022-01-28C16284748780-1d6a99b39-bb08-a426-e053-dadaa90af4c2OIDO ® SANA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1100-1OIDO SANA1 in 1 CARTONSOLUTION15
58988-1100-1OIDO SANA30 mL in 1 BOTTLE, PLASTICSOLUTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1100OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]5Current NDC, Legacy NDC, 2 package rows20241226_71e84695-49e8-459f-ac5e-118b5235fe06.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1

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
58988-110058988-1100-1

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
ndc (package): 58988-1100-1
ndc (product): 58988-1100
ndc11 (package): 58988110001
spl id: fd1d6b7b-081c-4b49-95f2-4a5650c9d188
spl set id: 71e84695-49e8-459f-ac5e-118b5235fe06

Reported adverse events (FAERS/openFDA)#

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