FDA.reportPublic FDA data

Organic Antiseptic Gel Hand Sanitizer

Manufacturer
Bioagaves de la Costa, S.A. de C.V.
Effective date
2020-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:37

Label at a glance#

ProductOrganic Antiseptic Gel Hand Sanitizer 80 v/v
Active ingredientALCOHOL
Label structure8 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Organic Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that can potencially 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.

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

SPL UNCLASSIFIED SECTION

  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Organic aloe vera, glycerin, purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel 2label 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76598-008-012023-01-30C16284748780-1f386c649-b808-0266-e053-dadaa90a7c1aab3a4f7b-1b0b-25bf-e053-2a95a90a3b6c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-008-01Organic Antiseptic Gel Hand Sanitizer80 v/v4 mL in 1 POUCHGEL41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-008ORGANIC ANTISEPTIC GEL HAND SANITIZER 80 V/V (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]1Legacy NDC, 1 package rows20200725_ab3a4f7b-1b0b-25bf-e053-2a95a90a3b6c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76598-00876598-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT

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
ab359f47-7979-e09b-e053-2a95a90a19acab3a4f7b-1b0b-25bf-e053-2a95a90a3b6c2020-07-24WarningsExact identifier
spl id: ab359f47-7979-e09b-e053-2a95a90a19ac
spl set id: ab3a4f7b-1b0b-25bf-e053-2a95a90a3b6c

Reported adverse events (FAERS/openFDA)#

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