FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GREEN ELV NUTRITION, S.A. DE C.V.
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:27:42

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

Help reduce bacteria, which could cause disease Recommended for repeated use

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub into hands until dry Children under 6 years should be supervised when using this product

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purposes

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • Help reduce bacteria, which could cause disease
  • Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For External Use Only.

When using this product,

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use & ask a doctor if

OTC - STOP USE SECTION

if irritation or redness develops and persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands
  • Rub into hands until dry
  • Children under 6 years should be supervised when using this product

Other information

SPL UNCLASSIFIED SECTION

  • Store below 86°F(30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbopol, Glycerin, Licorice Extract, Neem Extract, Propylene glicol, Triethanolamine, Water.

Question or comments?

OTC - QUESTIONS SECTION

+1(956) 612-8408

Package Labeling :250ml (Bag)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle250mlBottle250ml

Package Labeling :250ml(Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle 250mlBottle 250ml

Package Labeling :1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle 1LBottle 1L

Package Labeling :30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle 30mlBottle 30ml

Package Labeling :500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle500mlBottle500ml

Package Labeling :60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle60mlBottle60ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78659-000-012022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer
78659-000-022022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer
78659-000-032022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer
78659-000-042022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer
78659-000-052022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer
78659-000-062022-01-28C16284748780-1d6a99b39-c1e3-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78659-000HAND SANITIZER (ALCOHOL) GEL [GREEN ELV NUTRITION, S.A. DE C.V.]1Legacy NDC20200607_a759a736-2133-2772-e053-2a95a90a99fc.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78659-00078659-000-01, 78659-000-02, 78659-000-03, 78659-000-04, 78659-000-05, 78659-000-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
LICORICE61ZBX54883IACT
AZADIRACHTA INDICA FLOWER3TE8A92UPMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
a759a736-2134-2772-e053-2a95a90a99fca759a736-2133-2772-e053-2a95a90a99fc2020-06-05WarningsExact identifier
spl id: a759a736-2134-2772-e053-2a95a90a99fc
spl set id: a759a736-2133-2772-e053-2a95a90a99fc

Reported adverse events (FAERS/openFDA)#

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