FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Diquisa, S.A. de C.V | Diquisa, S.A. de C.V.
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:21

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

The hand sanitizer gel is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.2% v/v).
  3. Trolamine (0.15% v/v).
    d. Carbomer (0.3 % )
    e. Sterile distilled water or boiled cold water.

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

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, trolamine, carbomer, streriled or distilled water

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

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.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer 1 GallonHand Sanitizer 1 Gallon1 gallon NDC: 78361-002-04



1000 ml label1000 ml label

1000 ml NDC 78361-002-06

500 ml label500 ml label500 ml NDC 78361-002-07


250 ml label250 ml label250 ml NDC 78361-002-08


60 ml label60 ml label60 ml NDC 78361-002-09

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78361-002-052022-01-28C16284748780-1d6a99b39-4db8-a426-e053-dadaa90af4c2Hand Sanitizer Gel
78361-002-062022-01-28C16284748780-1d6a99b39-4db8-a426-e053-dadaa90af4c2Hand Sanitizer Gel
78361-002-072022-01-28C16284748780-1d6a99b39-4db8-a426-e053-dadaa90af4c2Hand Sanitizer Gel
78361-002-082022-01-28C16284748780-1d6a99b39-4db8-a426-e053-dadaa90af4c2Hand Sanitizer Gel
78361-002-092022-01-28C16284748780-1d6a99b39-4db8-a426-e053-dadaa90af4c2Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78361-002-05Hand Sanitizer3780 mL in 1 BOTTLEGEL37803
78361-002-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
78361-002-07Hand Sanitizer500 mL in 1 BOTTLEGEL5003
78361-002-08Hand Sanitizer250 mL in 1 BOTTLEGEL2503
78361-002-09Hand Sanitizer60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78361-002HAND SANITIZER (ALCOHOL) GEL [DIQUISA, S.A. DE C.V]3Legacy NDC, 5 package rows20200607_a67e63dc-0115-1834-e053-2995a90a4d40.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
78361-00278361-002-05, 78361-002-06, 78361-002-07, 78361-002-08, 78361-002-09

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a75d586d-2f2c-f796-e053-2995a90ac776a67e63dc-0115-1834-e053-2995a90a4d402020-06-05WarningsExact identifier
spl id: a75d586d-2f2c-f796-e053-2995a90ac776
spl set id: a67e63dc-0115-1834-e053-2995a90a4d40

Reported adverse events (FAERS/openFDA)#

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