FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Dura Micro Inc | Dura Miro Inc
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:19

Label at a glance#

ProductInstant Hand 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

Isopropyl Alcohol 75% 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Propylene, Glycol, Sodium Hydroxide, Perfume, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 ml NDC: 78801-075-10

100ml Label100ml Label

50 ml NDC : 78801-075-05

50ml Label50ml Label

500 ml NDC : 78801-075-50

500ml Label500ml Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78801-075-052022-01-28C16284748780-1d6a99b39-f587-a426-e053-dadaa90af4c2a749e189-c5ea-a54a-e053-2a95a90a48d0
78801-075-102022-01-28C16284748780-1d6a99b39-f587-a426-e053-dadaa90af4c2a749e189-c5ea-a54a-e053-2a95a90a48d0
78801-075-502022-01-28C16284748780-1d6a99b39-f587-a426-e053-dadaa90af4c2a749e189-c5ea-a54a-e053-2a95a90a48d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78801-075-05Instant Hand Sanitizer50 mL in 1 BOTTLE, DISPENSINGGEL501
78801-075-10Instant Hand Sanitizer100 mL in 1 BOTTLE, DISPENSINGGEL1001
78801-075-50Instant Hand Sanitizer500 mL in 1 BOTTLE, DISPENSINGGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78801-075INSTANT HAND SANITIZER (ALCOHOL) GEL [DURA MICRO INC]1Legacy NDC, 3 package rows20200612_a749e189-c5ea-a54a-e053-2a95a90a48d0.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78801-07578801-075-05, 78801-075-10, 78801-075-50
72505-013

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
a749dbc8-f377-1141-e053-2a95a90afa5ea749e189-c5ea-a54a-e053-2a95a90a48d02020-06-04WarningsExact identifier
spl id: a749dbc8-f377-1141-e053-2a95a90afa5e
spl set id: a749e189-c5ea-a54a-e053-2a95a90a48d0

Reported adverse events (FAERS/openFDA)#

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