FDA.reportPublic FDA data

Hand Defender

Manufacturer
Gm Integraciones y Soluciones en Control, S.A. de C.V.
Effective date
2020-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:19

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

Purified Water, Glycerin, Carbopol, Triethanolamine

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77377-001-012022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-022022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-032022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-042022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-052022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-062022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-072022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-082022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-092022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-102022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-112022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-122022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-132022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-142022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14
77377-001-152022-01-28C16284748780-1d6a99b39-5745-a426-e053-dadaa90af4c295bf2263-4e89-45ff-9c5c-24c89bf38e14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77377-001-01Hand Defender60 mL in 1 BOTTLEGEL601
77377-001-02Hand Defender120 mL in 1 BOTTLEGEL1201
77377-001-03Hand Defender125 mL in 1 BOTTLEGEL1251
77377-001-04Hand Defender250 mL in 1 BOTTLEGEL2501
77377-001-05Hand Defender500 mL in 1 BOTTLEGEL5001
77377-001-06Hand Defender540 mL in 1 BOTTLEGEL5401
77377-001-07Hand Defender700 mL in 1 BOTTLEGEL7001
77377-001-08Hand Defender750 mL in 1 BOTTLEGEL7501
77377-001-09Hand Defender1000 mL in 1 BOTTLEGEL10001
77377-001-10Hand Defender5000 mL in 1 BOTTLEGEL50001
77377-001-11Hand Defender10000 mL in 1 BOTTLEGEL100001
77377-001-12Hand Defender20000 mL in 1 BOTTLEGEL200001
77377-001-13Hand Defender220000 mL in 1 BOTTLEGEL2200001
77377-001-14Hand Defender1000000 mL in 1 BOTTLEGEL10000001
77377-001-15Hand Defender200000 mL in 1 BOTTLEGEL2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77377-001HAND DEFENDER (ALCOHOL) GEL [GM INTEGRACIONES Y SOLUCIONES EN CONTROL, S.A. DE C.V.]1Legacy NDC, 15 package rows20200509_95bf2263-4e89-45ff-9c5c-24c89bf38e14.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
77377-00177377-001-01, 77377-001-02, 77377-001-03, 77377-001-04, 77377-001-05, 77377-001-06, 77377-001-07, 77377-001-08, 77377-001-09, 77377-001-10, 77377-001-11, 77377-001-12, 77377-001-13, 77377-001-14, 77377-001-15

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT

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
a13cfa56-ad4f-43a1-b66a-e683d08b096895bf2263-4e89-45ff-9c5c-24c89bf38e142020-05-08WarningsExact identifier
spl id: a13cfa56-ad4f-43a1-b66a-e683d08b0968
spl set id: 95bf2263-4e89-45ff-9c5c-24c89bf38e14

Reported adverse events (FAERS/openFDA)#

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