FDA.reportPublic FDA data

Organic Antiseptic Gel

Manufacturer
Bioagaves de la Costa, S.A. de C.V.
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:11:13

Label at a glance#

ProductOrganic Antiseptic Gel
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 potencially 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 mouht. 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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Organic glycerin, carbomer, triethanolamine, purified water USP, organic aloe vera.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN3
1041498ethanol 0.8 ML/ML Topical GelSCD3
1041498ethanol 80 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76598-002-012023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-022023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-032023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-042023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-052023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-062023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-072023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-082023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90
76598-002-092023-01-30C16284748780-1f386c649-bf79-0266-e053-dadaa90a7c1aa40f5348-5452-f910-e053-2995a90a8e90

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-002-01Organic Antiseptic Gel250 mL in 1 BOTTLEGEL2503
76598-002-02Organic Antiseptic Gel500 mL in 1 BOTTLEGEL5003
76598-002-03Organic Antiseptic Gel1000 mL in 1 BOTTLEGEL10003
76598-002-04Organic Antiseptic Gel5000 mL in 1 BOTTLEGEL50003
76598-002-05Organic Antiseptic Gel20000 mL in 1 PACKAGEGEL200003
76598-002-06Organic Antiseptic Gel200000 mL in 1 DRUMGEL2000003
76598-002-07Organic Antiseptic Gel1000000 mL in 1 TANKGEL10000003
76598-002-08Organic Antiseptic Gel4500 mL in 1 BOTTLEGEL45003
76598-002-09Organic Antiseptic Gel60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-002ORGANIC ANTISEPTIC GEL (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]3Legacy NDC, 9 package rows20200514_a40f5348-5452-f910-e053-2995a90a8e90.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
76598-00276598-002-01, 76598-002-02, 76598-002-03, 76598-002-04, 76598-002-05, 76598-002-06, 76598-002-07, 76598-002-08, 76598-002-09

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
a58fd8fd-27bd-f4b0-e053-2995a90af472a40f5348-5452-f910-e053-2995a90a8e902020-05-13WarningsExact identifier
spl id: a58fd8fd-27bd-f4b0-e053-2995a90af472
spl set id: a40f5348-5452-f910-e053-2995a90a8e90

Reported adverse events (FAERS/openFDA)#

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