FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Diquisa, S.A. De C.V.
Effective date
2020-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 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 59ºF-86ºF (15ºC-30ºC) Avoid freezing and excessive heat above 104ºF (40ºC)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v.

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 59ºF-86ºF (15ºC-30ºC)
  • Avoid freezing and excessive heat above 104ºF (40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Purified water, Trolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3780 mL NDC: 78361-003-01

3780ml label3780ml label
1000 mL NDC: 78361-003-02
1000ml front label1000ml front label 1000ml back label1000ml back label
500 mL NDC: 78361-003-03
500ml front label500ml front label 500ml back label500ml back label
250 mL NDC: 78361-003-04
250ml front label250ml front label 250ml back label250ml back label
330 mL NDC: 78361-003-05
330ml front label330ml front label 330ml back label330ml back label
60 mL NDC: 78361-003-06
60ml label60ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78361-003-012022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer
78361-003-022022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer
78361-003-032022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer
78361-003-042022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer
78361-003-052022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer
78361-003-062022-01-28C16284748780-1d6a99b39-9314-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78361-003-01Hand Sanitizer3780 mL in 1 BOTTLEGEL37802
78361-003-02Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
78361-003-03Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78361-003-04Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78361-003-05Hand Sanitizer330 mL in 1 BOTTLEGEL3302
78361-003-06Hand Sanitizer60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78361-003HAND SANITIZER (ALCOHOL) GEL [DIQUISA, S.A. DE C.V.]2Legacy NDC, 6 package rows20200815_aae557f5-e669-876f-e053-2995a90ad81c.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
78361-00378361-003-01, 78361-003-02, 78361-003-03, 78361-003-04, 78361-003-05, 78361-003-06

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
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT

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
ac39ce3c-b3c7-2bd2-e053-2a95a90a32a5aae557f5-e669-876f-e053-2995a90ad81c2020-08-06WarningsExact identifier
spl id: ac39ce3c-b3c7-2bd2-e053-2a95a90a32a5
spl set id: aae557f5-e669-876f-e053-2995a90ad81c

Reported adverse events (FAERS/openFDA)#

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