FDA.reportPublic FDA data

Hand Defender

Manufacturer
Gm Integraciones y Soluciones en Control, S.A. de C.V.
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:34

Label at a glance#

ProductHand Defender
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

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

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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

  • in children less than 2 months of age
  • on open skin wounds

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.

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

Glycerin and purified water

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
77377-002-012022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-022022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-032022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-042022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-052022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-062022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-072022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-082022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-092022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-102022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-112022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-122022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-132022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-142022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-152022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-162022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-172022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-182022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-192022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-202022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-212022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-222022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99
77377-002-232022-01-28C16284748780-1d6a99b39-c403-a426-e053-dadaa90af4c256b6f4f6-1347-4782-b00c-ef681a344c99

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77377-002-01Hand Defender1 mL in 1 POUCHLIQUID11
77377-002-02Hand Defender2 mL in 1 POUCHLIQUID21
77377-002-03Hand Defender10 mL in 1 POUCHLIQUID101
77377-002-04Hand Defender30 mL in 1 BOTTLELIQUID301
77377-002-05Hand Defender60 mL in 1 BOTTLELIQUID601
77377-002-06Hand Defender120 mL in 1 BOTTLELIQUID1201
77377-002-07Hand Defender125 mL in 1 BOTTLELIQUID1251
77377-002-08Hand Defender250 mL in 1 BOTTLELIQUID2501
77377-002-09Hand Defender500 mL in 1 BOTTLELIQUID5001
77377-002-10Hand Defender540 mL in 1 BOTTLELIQUID5401
77377-002-11Hand Defender700 mL in 1 BOTTLELIQUID7001
77377-002-12Hand Defender750 mL in 1 BOTTLELIQUID7501
77377-002-13Hand Defender1000 mL in 1 BOTTLELIQUID10001
77377-002-14Hand Defender1900 mL in 1 BOTTLELIQUID19001
77377-002-15Hand Defender2000 mL in 1 BOTTLELIQUID20001
77377-002-16Hand Defender3780 mL in 1 BOTTLELIQUID37801
77377-002-17Hand Defender4000 mL in 1 BOTTLELIQUID40001
77377-002-18Hand Defender5000 mL in 1 BOTTLELIQUID50001
77377-002-19Hand Defender10000 mL in 1 BOTTLELIQUID100001
77377-002-20Hand Defender20000 mL in 1 BOTTLELIQUID200001
77377-002-21Hand Defender200000 mL in 1 BOTTLELIQUID2000001
77377-002-22Hand Defender220000 mL in 1 BOTTLELIQUID2200001
77377-002-23Hand Defender1000000 mL in 1 BOTTLELIQUID10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77377-002HAND DEFENDER (ALCOHOL) LIQUID [GM INTEGRACIONES Y SOLUCIONES EN CONTROL, S.A. DE C.V.]1Legacy NDC, 23 package rows20200709_56b6f4f6-1347-4782-b00c-ef681a344c99.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77377-00277377-002-01, 77377-002-02, 77377-002-03, 77377-002-04, 77377-002-05, 77377-002-06, 77377-002-07, 77377-002-08, 77377-002-09, 77377-002-10, 77377-002-11, 77377-002-12, 77377-002-13, 77377-002-14, 77377-002-15, 77377-002-16, 77377-002-17, 77377-002-18, 77377-002-19, 77377-002-20, 77377-002-21, 77377-002-22, 77377-002-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
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
238c4e58-6cf3-4f05-8387-a27eb11f98d856b6f4f6-1347-4782-b00c-ef681a344c992020-07-03WarningsExact identifier
spl id: 238c4e58-6cf3-4f05-8387-a27eb11f98d8
spl set id: 56b6f4f6-1347-4782-b00c-ef681a344c99

Reported adverse events (FAERS/openFDA)#

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