FDA.reportPublic FDA data

Antiseptic Gel Hand Sanitizer

Manufacturer
Bioagaves de la Costa, S.A. de C.V.
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:26:46

Label at a glance#

ProductAntiseptic Gel Hand Sanitizer 70 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

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, carbomer, triethanolamine, purified water USP, aloe vera.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 3label 3label 2label 2labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76598-004-012023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-022023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-032023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-042023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-052023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-062023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-072023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-082023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-092023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-102023-01-30C16284748780-1f386c64a-44aa-0266-e053-dadaa90a7c1aa873f92e-561a-f1e8-e053-2995a90ad2f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76598-004-01Antiseptic Gel Hand Sanitizer70 v/v200 mL in 1 BOTTLEGEL2002
76598-004-02Antiseptic Gel Hand Sanitizer70 v/v60 mL in 1 BOTTLEGEL602
76598-004-03Antiseptic Gel Hand Sanitizer70 v/v250 mL in 1 BOTTLEGEL2502
76598-004-04Antiseptic Gel Hand Sanitizer70 v/v500 mL in 1 BOTTLEGEL5002
76598-004-05Antiseptic Gel Hand Sanitizer70 v/v1000 mL in 1 PACKAGEGEL10002
76598-004-06Antiseptic Gel Hand Sanitizer70 v/v3785 mL in 1 DRUMGEL37852
76598-004-07Antiseptic Gel Hand Sanitizer70 v/v1000000 mL in 1 TANKGEL10000002
76598-004-08Antiseptic Gel Hand Sanitizer70 v/v20000 mL in 1 DRUMGEL200002
76598-004-09Antiseptic Gel Hand Sanitizer70 v/v200000 mL in 1 TANKGEL2000002
76598-004-10Antiseptic Gel Hand Sanitizer70 v/v4 mL in 1 POUCHGEL42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76598-004ANTISEPTIC GEL HAND SANITIZER 70 V/V (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]2Legacy NDC, 10 package rows20200904_a873f92e-561a-f1e8-e053-2995a90ad2f3.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
76598-00476598-004-01, 76598-004-02, 76598-004-03, 76598-004-04, 76598-004-05, 76598-004-06, 76598-004-07, 76598-004-08, 76598-004-09, 76598-004-10

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
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
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
ae6ae49e-97c8-9ba1-e053-2a95a90ac170a873f92e-561a-f1e8-e053-2995a90ad2f32020-09-03WarningsExact identifier
spl id: ae6ae49e-97c8-9ba1-e053-2a95a90ac170
spl set id: a873f92e-561a-f1e8-e053-2995a90ad2f3

Reported adverse events (FAERS/openFDA)#

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