FDA.reportPublic FDA data

Ethylalcohol 70% Hand sanitizer solution

Manufacturer
Seaway Pharma Inc.
Effective date
2020-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:16

Label at a glance#

ProductAlcohol Antiseptic
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 70% v/v.............................. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

  • on 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.

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

aloe vera gel, amino methyl propanol, carbomer, FD&C blue #1·, FD&C yellow #10·, fragrance, purified water, vitamin E
•may contain one or more of these ingredients if the product is a colored gel.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 fl oz (237 mL) NDC: 73414-057-08

containerlabel8flozcontainerlabel8floz

16 fl oz (473 mL) NDC: 73414-057-13

containerlabel16flozcontainerlabel16floz

32 fl oz (946 mL) NDC: 73414-057-14

containerlabe32flozcontainerlabe32floz

1 Gallon (3.78 L) NDC: 73414-057-91

containerlabel1galcontainerlabel1gal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73414-057-012022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-042022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-062022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-082022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-132022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-142022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution
73414-057-912022-01-28C16284748780-1d6a99b39-adf0-a426-e053-dadaa90af4c2Ethylalcohol 70% Hand sanitizer solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73414-057-01Alcohol Antiseptic59 mL in 1 BOTTLESOLUTION591
73414-057-04Alcohol Antiseptic118 mL in 1 BOTTLESOLUTION1181
73414-057-06Alcohol Antiseptic177 mL in 1 BOTTLESOLUTION1771
73414-057-08Alcohol Antiseptic177 mL in 1 BOTTLESOLUTION1771
73414-057-13Alcohol Antiseptic473 mL in 1 BOTTLESOLUTION4731
73414-057-14Alcohol Antiseptic946 mL in 1 BOTTLESOLUTION9461
73414-057-91Alcohol Antiseptic3780 mL in 1 BOTTLESOLUTION37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73414-057ALCOHOL ANTISEPTIC (ALCOHOL) SOLUTION [SEAWAY PHARMA INC.]1Legacy NDC, 7 package rows20200820_d3d8f36e-8e7f-4e18-a405-af49034656b8.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
73414-05773414-057-01, 73414-057-04, 73414-057-06, 73414-057-08, 73414-057-13, 73414-057-14, 73414-057-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT

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
b4685e39-5924-4a0b-a29b-55a55de3e558d3d8f36e-8e7f-4e18-a405-af49034656b82020-07-26WarningsExact identifier
spl id: b4685e39-5924-4a0b-a29b-55a55de3e558
spl set id: d3d8f36e-8e7f-4e18-a405-af49034656b8

Reported adverse events (FAERS/openFDA)#

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