Hand Sanitizer

Manufacturer
Agroorganika UAB
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:58

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

NDC 78897-001: glycerin, hydrogen peroxide, purified water USP, Fragrance Honey Melon

NDC 78897-002: glycerin, hydrogen peroxide, purified water USP, Fragrance Watermelon

NDC 78897-003: glycerin, hydrogen peroxide, purified water USP, Fragrance Mint

Other information

STORAGE AND HANDLING SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 78897-001-01

100 mL melon flavor100 mL melon flavor

500 mL NDC: 78897-001-02

500 mL melon flavor500 mL melon flavor

1000 mL NDC: 78897-001-03

1000 mL melon flavor1000 mL melon flavor

4000 mL NDC: 78897-001-04

4000 mL melon flavor4000 mL melon flavor

100 mL NDC: 78897-002-01

100 mL watermelon flavor100 mL watermelon flavor

500 mL NDC: 78897-002-02

500 mL watermelon flavor500 mL watermelon flavor

1000 mL NDC: 78897-002-03

1000 mL watermelon flavor1000 mL watermelon flavor

4000 mL NDC: 78897-002-04

4000 mL watermelon flavor4000 mL watermelon flavor

100 mL NDC: 78897-003-01

100 mL mint flavor100 mL mint flavor

500 mL NDC: 78897-003-02

500 ml mint flavor500 ml mint flavor

1000 mL NDC: 78897-003-03

1000 mL mint flavor1000 mL mint flavor

4000 mL NDC: 78897-003-04

4000 mL mint flavor4000 mL mint flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78897-001-01Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1001
78897-001-02Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5001
78897-001-03Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
78897-001-04Hand Sanitizer4000 mL in 1 BAGLIQUID40001
78897-002-01Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1001
78897-002-02Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5001
78897-002-03Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
78897-002-04Hand Sanitizer4000 mL in 1 BAGLIQUID40001
78897-003-01Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1001
78897-003-02Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5001
78897-003-03Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
78897-003-04Hand Sanitizer4000 mL in 1 BAGLIQUID40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78897-001HAND SANITIZER (ALCOHOL) LIQUID [AGROORGANIKA UAB]1Legacy NDC, 4 package rows20200729_ab72c775-f42a-9eec-e053-2a95a90a475f.zip
78897-002HAND SANITIZER (ALCOHOL) LIQUID [AGROORGANIKA UAB]1Legacy NDC, 4 package rows20200729_ab72c775-f42a-9eec-e053-2a95a90a475f.zip
78897-003HAND SANITIZER (ALCOHOL) LIQUID [AGROORGANIKA UAB]1Legacy NDC, 4 package rows20200729_ab72c775-f42a-9eec-e053-2a95a90a475f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
ab71c4eb-9d49-31c1-e053-2a95a90af215ab72c775-f42a-9eec-e053-2a95a90a475f2020-07-27WarningsExact identifier
spl id: ab71c4eb-9d49-31c1-e053-2a95a90af215
spl set id: ab72c775-f42a-9eec-e053-2a95a90a475f

Reported adverse events (FAERS/openFDA)#

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