FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GIA EVOLUTION SA DE CV
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:17:04

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)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 72% 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP, glycerin, carbomer, triethanolamine and vitamin E

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

29.5 mL NDC: 77231-040-04 29.5 mL29.5 mL

59 mL NDC: 77231-040-05 59 mL59 mL

237 mL NDC: 77231-040-07 237 mL237 mL

500 mL NDC: 77231-040-08 500 mL500 mL

946 mL NDC: 77231-040-09 946 mL946 mL

3785 mL NDC: 77231-040-10 3785 mL3785 mL

190 mL NDC: 77231-040-06 190 mL190 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN3
2277550ethanol 0.72 ML/ML Topical GelSCD3
2277550ethanol 72 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77231-040-042021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-052021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-062021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-072021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-082021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-092021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c
77231-040-102021-07-23C16284748780-1c7ccaba7-25f2-fd44-e053-dadaa90aa01ba6334900-a92c-a5b4-e053-2995a90abd8c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77231-040-04Hand Sanitizer29.57 mL in 1 BOTTLE, DISPENSINGGEL29.573
77231-040-05Hand Sanitizer59 mL in 1 BOTTLEGEL593
77231-040-06Hand Sanitizer190 mL in 1 BOTTLEGEL1903
77231-040-07Hand Sanitizer237 mL in 1 BOTTLEGEL2373
77231-040-08Hand Sanitizer500 mL in 1 BOTTLEGEL5003
77231-040-09Hand Sanitizer946 mL in 1 BOTTLEGEL9463
77231-040-10Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77231-040HAND SANITIZER (ALCOHOL) GEL [GIA EVOLUTION SA DE CV]3Legacy NDC, 7 package rows20200611_a6334900-a92c-a5b4-e053-2995a90abd8c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77231-04077231-040-10, 77231-040-04, 77231-040-05, 77231-040-07, 77231-040-08, 77231-040-09, 77231-040-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
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
a7c51546-3fb9-72e9-e053-2995a90a0e8da6334900-a92c-a5b4-e053-2995a90abd8c2020-06-10WarningsExact identifier
spl id: a7c51546-3fb9-72e9-e053-2995a90a0e8d
spl set id: a6334900-a92c-a5b4-e053-2995a90abd8c

Reported adverse events (FAERS/openFDA)#

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