FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Grupo Delveg, S.A. de C.V.
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:30:53

Label at a glance#

ProductHand Sanitizer Green
Active ingredientALCOHOL
Label structure20 sections

Dosage and administration

Put enough product in hands to cover them, rub them together briskly until dry. Children under 6 years old need adult supervision to use this product.

Storage and handling

Store in a cool, dry place at a temperature from 32°F to 95°F.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help to decrease bacteria on the skin that could cause disease. Recommended for repeted use.

Warnings

WARNINGS SECTION

For external use only: hands. Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

Keep out of eyes, in case of contact, flush thoroughly with water. Avoid contact with broken skin. Do not inhale nor ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children if swallowed, get medical help or contact a Poisson Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in hands to cover them, rub them together briskly until dry.
  • Children under 6 years old need adult supervision to use this product.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place at a temperature from 32°F to 95°F.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, demineralized water, glycerin, Microcare®CB (benzyl alcohol and a mixture of methylchloroisothiazolinone and methylisothiazolinone) and triethanolamine. May contain FD&C Blue No. 1, FD&C Blue No. 2, FD&C Yellow No. 5 (tartrazine) and/or FD&C Yellow No. 6.

OTC - QUESTIONS SECTION

Questions? +52 444 823 5650

Label NDC 79008-001

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-001-01

Hand Sanitizer Label SampleHand Sanitizer Label Sample

Label NDC: 79008-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

220 mL NDC: 79008-001-02

Hand Sanitizer Label 220 mlHand Sanitizer Label 220 ml

Label NDC 79008-001-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-001-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenserHand Sanitizer Label 1 L w/dispenser

Label NDC 79008-002-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-002-01

Hand Sanitizer LabelHand Sanitizer Label

Label NDC: 79008-002-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

220 mL NDC: 79008-002-02

Hand Sanitizer Label 220 mlHand Sanitizer Label 220 ml

Label NDC 79008-002-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-002-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenserHand Sanitizer Label 1 L w/dispenser

Label NDC 79008-003-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-003-01

Hand Sanitizer LabelHand Sanitizer Label

Label NDC: 79008-003-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

220 mL NDC: 79008-003-02

Hand Sanitizer Label 220 mlHand Sanitizer Label 220 ml

Label NDC 79008-003-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79008-003-03

Bottle w/dispenser

Hand Sanitizer Label 1 L w/dispenserHand Sanitizer Label 1 L w/dispenser

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
79008-001-012022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-001-022022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-001-032022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-002-012022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-002-022022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-002-032022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-003-012022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-003-022022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer
79008-003-032022-01-28C16284748780-1d6a99b39-fc21-a426-e053-dadaa90af4c2Gomina Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79008-001-01Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
79008-001-02Hand Sanitizer220 mL in 1 BOTTLEGEL2203
79008-001-03Hand Sanitizer1000 mL in 1 BOTTLE, DISPENSINGGEL10003
79008-002-01Hand SanitizerGreen1000 mL in 1 BOTTLEGEL10003
79008-002-02Hand SanitizerGreen220 mL in 1 BOTTLEGEL2203
79008-002-03Hand SanitizerGreen1000 mL in 1 BOTTLE, DISPENSINGGEL10003
79008-003-01Hand SanitizerBlue1000 mL in 1 BOTTLEGEL10003
79008-003-02Hand SanitizerBlue220 mL in 1 BOTTLEGEL2203
79008-003-03Hand SanitizerBlue1000 mL in 1 BOTTLE, DISPENSINGGEL10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79008-001HAND SANITIZER GREEN (ALCOHOL) GEL HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER BLUE (ALCOHOL) GEL [GRUPO DELVEG, S.A. DE C.V.]3Legacy NDC, 3 package rows20201003_a82495fb-2194-b21c-e053-2a95a90acccf.zip
79008-002HAND SANITIZER GREEN (ALCOHOL) GEL HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER BLUE (ALCOHOL) GEL [GRUPO DELVEG, S.A. DE C.V.]3Legacy NDC, 3 package rows20201003_a82495fb-2194-b21c-e053-2a95a90acccf.zip
79008-003HAND SANITIZER GREEN (ALCOHOL) GEL HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER BLUE (ALCOHOL) GEL [GRUPO DELVEG, S.A. DE C.V.]3Legacy NDC, 3 package rows20201003_a82495fb-2194-b21c-e053-2a95a90acccf.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79008-00179008-001-01, 79008-001-02, 79008-001-03
79008-00279008-002-01, 79008-002-02, 79008-002-03
79008-00379008-003-01, 79008-003-02, 79008-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT

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
b0b3a299-1206-39d7-e053-2995a90ac441a82495fb-2194-b21c-e053-2a95a90acccf2020-10-02WarningsExact identifier
spl id: b0b3a299-1206-39d7-e053-2995a90ac441
spl set id: a82495fb-2194-b21c-e053-2a95a90acccf

Reported adverse events (FAERS/openFDA)#

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