FDA.reportPublic FDA data

SantOtizer E80- FRAGRANCE

Manufacturer
SantoLubes LLC
Effective date
2021-04-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:40:05

Label at a glance#

ProductSantOtizer E80- FRAGRANCE
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

1.3oz1.3ozAlcohol 80% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use

In children less than 2 months of age
On open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

fragrance, glycerin, hydrogen peroxide, purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3600 ml label3600 ml label18000 ml label18000 ml label200000 ml label200000 ml label1022000 ml label1022000 ml label3,600ml NDC 73976-3304-1

18,000ml NDC 73976-3304-2

200,000ml NDC 73976-3304-3

1,022,00ml NDC 73976-3304-4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN5
1039339ethanol 0.8 ML/ML Topical SolutionSCD5
1039339ethanol 80 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73976-3304-12023-01-30C16284748780-1f386c649-bb73-0266-e053-dadaa90a7c1aa7d5f6c9-79e9-1d56-e053-2a95a90a4ec1
73976-3304-22023-01-30C16284748780-1f386c649-bb73-0266-e053-dadaa90a7c1aa7d5f6c9-79e9-1d56-e053-2a95a90a4ec1
73976-3304-32023-01-30C16284748780-1f386c649-bb73-0266-e053-dadaa90a7c1aa7d5f6c9-79e9-1d56-e053-2a95a90a4ec1
73976-3304-42023-01-30C16284748780-1f386c649-bb73-0266-e053-dadaa90a7c1aa7d5f6c9-79e9-1d56-e053-2a95a90a4ec1
73976-3304-62023-01-30C16284748780-1f386c649-bb73-0266-e053-dadaa90a7c1aa7d5f6c9-79e9-1d56-e053-2a95a90a4ec1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73976-3304-1SantOtizer E80- FRAGRANCE3600 mL in 1 PAILLIQUID36005
73976-3304-2SantOtizer E80- FRAGRANCE18000 mL in 1 PAILLIQUID180005
73976-3304-3SantOtizer E80- FRAGRANCE200000 mL in 1 DRUMLIQUID2000005
73976-3304-4SantOtizer E80- FRAGRANCE1022000 mL in 1 TANKLIQUID10220005
73976-3304-6SantOtizer E80- FRAGRANCE38.4456 mL in 1 BOTTLE, SPRAYLIQUID38.44565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73976-3304SANTOTIZER E80- FRAGRANCE (HAND SANITIZER SOLUTION) LIQUID [SANTOLUBES LLC]5Legacy NDC, 5 package rows20210430_a7d5f6c9-79e9-1d56-e053-2a95a90a4ec1.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73976-330473976-3304-1, 73976-3304-2, 73976-3304-3, 73976-3304-4, 73976-3304-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
c11f265f-4bb9-3686-e053-2a95a90ad6f4a7d5f6c9-79e9-1d56-e053-2a95a90a4ec12021-04-29WarningsExact identifier
spl id: c11f265f-4bb9-3686-e053-2a95a90ad6f4
spl set id: a7d5f6c9-79e9-1d56-e053-2a95a90a4ec1

Reported adverse events (FAERS/openFDA)#

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