FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Corporativo Industrial Bioclean, S.A. de C.V.
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use.

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. Condition persists for more than 72 hours.

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.

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised when using this product.

OTHER SAFETY INFORMATION

Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Glycerine, Carbomer and Methylchloroisothiazolinone/Methylisothiazolinone Mixture

OTC - QUESTIONS SECTION

Questions? Call +52-331-593-0253

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WAB GEL 2L NDC: 78100-300-10

WAB 2LWAB 2L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78100-300-102022-07-29C16284748780-1e4f33bdf-a64b-d8a0-e053-dadaa90a6e4eb029058b-b193-287d-e053-2995a90a1baa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78100-300-10Hand Sanitizer2 L in 1 BOTTLEGEL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78100-300HAND SANITIZER (ALCOHOL) GEL [CORPORATIVO INDUSTRIAL BIOCLEAN, S.A. DE C.V.]2Legacy NDC, 1 package rows20210717_b029058b-b193-287d-e053-2995a90a1baa.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
78100-30078100-300-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
TROLAMINE9O3K93S3TKIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
c7443575-9c93-b9c6-e053-2995a90a5760b029058b-b193-287d-e053-2995a90a1baa2021-07-16WarningsExact identifier
spl id: c7443575-9c93-b9c6-e053-2995a90a5760
spl set id: b029058b-b193-287d-e053-2995a90a1baa

Reported adverse events (FAERS/openFDA)#

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