FDA.reportPublic FDA data

BaciBan Gel

Manufacturer
Bonaventura Industries Inc
Effective date
2020-08-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:31

Label at a glance#

ProductBaciBan
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the hands

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

Storage and handling

•Store between 15-30C • Avoid freezing and excessive heat above 40C (104F) • may discolor some fabrics • harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl Alcohol 80%

Drug Facts SectionDrug Facts Section

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the hands

Warnings

WARNINGS SECTION

For external use only-hands.

Flammable. Keep away from heat and flame. Do not use in

children less than 2 months of age on open skin wounds

Do Not Use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth.

In case of contact with eyes, flush thoroughly with water.

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

STORAGE AND HANDLING SECTION

•Store between 15-30C

• Avoid freezing and excessive heat above 40C (104F)

• may discolor some fabrics • harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Guaraprolose, Citric Acid, Purified Water USP

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BaciBan LabelBaciBan Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77330-003-012022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel
77330-003-022022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel
77330-003-042022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel
77330-003-082022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel
77330-003-162022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel
77330-003-322022-01-28C16284748780-1d6a99b39-7a31-a426-e053-dadaa90af4c2BaciBan Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77330-003-01BaciBan3758 mL in 1 BOTTLE, PLASTICGEL37582
77330-003-02BaciBan59 mL in 1 BOTTLE, PLASTICGEL592
77330-003-04BaciBan118 mL in 1 BOTTLE, PLASTICGEL1182
77330-003-08BaciBan236 mL in 1 BOTTLE, PLASTICGEL2362
77330-003-16BaciBan473 mL in 1 BOTTLE, PLASTICGEL4732
77330-003-32BaciBan946 mL in 1 BOTTLE, PLASTICGEL9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77330-003BACIBAN (GEL SANITIZER) GEL [BONAVENTURA INDUSTRIES INC]2Legacy NDC, 6 package rows20200823_ab9b3d38-1411-d2c0-e053-2995a90a5398.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77330-00377330-003-01, 77330-003-02, 77330-003-04, 77330-003-08, 77330-003-16, 77330-003-32
75682-435

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GUARAPROLOSE (3500 MPA.S AT 1%)3A1I7376TCIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
ad719fb8-e314-5d23-e053-2995a90ac8a4ab9b3d38-1411-d2c0-e053-2995a90a53982020-08-22WarningsExact identifier
spl id: ad719fb8-e314-5d23-e053-2995a90ac8a4
spl set id: ab9b3d38-1411-d2c0-e053-2995a90a5398

Reported adverse events (FAERS/openFDA)#

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