FDA.reportPublic FDA data

Alcohol-Free Antiseptic Gel

Manufacturer
Bioagaves de la Costa, S.A. de C.V.
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:56

Label at a glance#

ProductAlcohol-Free Antiseptic Gel
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Place just one drop on hands to cover all surfaces.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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

Do not freeze. For external use only.

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 just one drop on hands to cover all surfaces.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel 2label 2label 3label 3label 4label 4label 5label 5label 6label 6label 7label 7label 8label 8label 9label 9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76598-010-012023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-022023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-032023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-042023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-052023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-062023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-072023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-082023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-092023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97
76598-010-102023-01-30C16284748780-1f386c649-f8d9-0266-e053-dadaa90a7c1aadc00888-033c-d9a1-e053-2995a90a7d97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-010-01Alcohol-Free Antiseptic Gel4 mL in 1 POUCHGEL41
76598-010-02Alcohol-Free Antiseptic Gel60 mL in 1 BOTTLEGEL601
76598-010-03Alcohol-Free Antiseptic Gel250 mL in 1 BOTTLEGEL2501
76598-010-04Alcohol-Free Antiseptic Gel500 mL in 1 BOTTLEGEL5001
76598-010-05Alcohol-Free Antiseptic Gel1000 mL in 1 BOTTLEGEL10001
76598-010-06Alcohol-Free Antiseptic Gel3780 mL in 1 BOTTLEGEL37801
76598-010-07Alcohol-Free Antiseptic Gel4500 mL in 1 BOTTLEGEL45001
76598-010-08Alcohol-Free Antiseptic Gel20000 mL in 1 JUGGEL200001
76598-010-09Alcohol-Free Antiseptic Gel200000 mL in 1 JUGGEL2000001
76598-010-10Alcohol-Free Antiseptic Gel1000000 mL in 1 JUGGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-010ALCOHOL-FREE ANTISEPTIC GEL (BENZALKONIUM CHLORIDE) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]1Legacy NDC, 10 package rows20200827_adc00888-033c-d9a1-e053-2995a90a7d97.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76598-01076598-010-01, 76598-010-02, 76598-010-03, 76598-010-04, 76598-010-05, 76598-010-06, 76598-010-07, 76598-010-08, 76598-010-09, 76598-010-10

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
adc00888-033b-d9a1-e053-2995a90a7d97adc00888-033c-d9a1-e053-2995a90a7d972020-08-25WarningsExact identifier
spl id: adc00888-033b-d9a1-e053-2995a90a7d97
spl set id: adc00888-033c-d9a1-e053-2995a90a7d97

Reported adverse events (FAERS/openFDA)#

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