FDA.reportPublic FDA data

Alcohol-Free Anitseptic Gel

Manufacturer
Bioagaves de la Costa, S.A. de C.V.
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:17:01

Label at a glance#

ProductAlcohol-Free Anitseptic 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

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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
76598-00976598-009-01, 76598-009-02, 76598-009-03, 76598-009-04, 76598-009-05, 76598-009-06, 76598-009-07, 76598-009-08, 76598-009-09, 76598-009-10

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
ae6a3b34-f83b-70cc-e053-2a95a90a0411adba2cd2-192f-afa6-e053-2995a90a3bcf2020-09-03WarningsExact identifier
spl set id: adba2cd2-192f-afa6-e053-2995a90a3bcf

Reported adverse events (FAERS/openFDA)#

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