FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Ava Food Labs, Inc.
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:40

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) You may report serious side effects to 2325 3rd St. #405, San Francisco, CA 94107

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.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • You may report serious side effects to 2325 3rd St. #405, San Francisco, CA 94107

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 74065-001-01

60mL spray label60mL spray label
3785 mL NDC: 74065-001-02

3.785L jug label3.785L jug label
3785 mL NDC: 74065-001-03

3.785L pouch label3.785L pouch label

208000 mL NDC: 74065-001-04

208L drum label208L drum label

1000000 mL NDC: 74065-001-05

1000L container label1000L container label

60 mL NDC: 74065-001-06

60mL bottle label60mL bottle label

375 mL NDC: 74065-001-07

375mL bottle label375mL bottle label

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74065-001-012022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-022022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-032022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-042022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-052022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-062022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West
74065-001-072022-01-28C16284748780-1d6a99b39-d53e-a426-e053-dadaa90af4c2Hand Sanitizer by Ava Food Labs, Inc. dba Endless West

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74065-001-01Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSOLUTION601
74065-001-02Hand Sanitizer3785 mL in 1 JUGSOLUTION37851
74065-001-03Hand Sanitizer3785 mL in 1 POUCHSOLUTION37851
74065-001-04Hand Sanitizer208000 mL in 1 DRUMSOLUTION2080001
74065-001-05Hand Sanitizer1000000 mL in 1 CONTAINERSOLUTION10000001
74065-001-06Hand Sanitizer60 mL in 1 BOTTLESOLUTION601
74065-001-07Hand Sanitizer375 mL in 1 BOTTLESOLUTION3751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74065-001HAND SANITIZER (ALCOHOL) SOLUTION [AVA FOOD LABS, INC.]1Legacy NDC, 7 package rows20200402_a219980f-a84a-8bdc-e053-2a95a90aaf3f.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74065-00174065-001-01, 74065-001-02, 74065-001-03, 74065-001-04, 74065-001-05, 74065-001-06, 74065-001-07

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a2199611-782f-dbb1-e053-2a95a90aa16da219980f-a84a-8bdc-e053-2a95a90aaf3f2020-03-30WarningsExact identifier
spl id: a2199611-782f-dbb1-e053-2a95a90aa16d
spl set id: a219980f-a84a-8bdc-e053-2a95a90aaf3f

Reported adverse events (FAERS/openFDA)#

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