Formula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:21:30

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Directions : Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions: Wet hands thoroughly with product and allow to dry without wiping.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

InActive Ingredients: Water, Carbomer, Triethanolamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Use: updated

RECENT MAJOR CHANGES SECTION

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek prompt medical attention.

OTC PURPOSE

OTC - PURPOSE SECTION

Purpose... Antiseptic

WARNING

WARNINGS SECTION

WARNINGS: For external use only

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.

Stop use and ask a doctor if irritation or redness develops and persists. If swallowed, seek prompt medical attention.

OTHER SAFETY INFORMATION

Other information: Non-staining, may discolor certain fabrics.

SAFE HANDLING WARNING SECTION

Flammable: Keep away from open flame.

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml30ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-116-002022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-012022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-022022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-042022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-052022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-082022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-092022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-102022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-122022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-152022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-162022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-182022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-252022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-282022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-322022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-552022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-642022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-702022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-992022-01-28C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-002020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-012020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-022020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-042020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-052020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-082020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-102020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-122020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-162020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-282020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-642020-07-16C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-002020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-012020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-022020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-042020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-052020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-082020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-102020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-122020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-162020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-282020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer
58418-116-642020-01-31C16284748780-19d75b9d0-e78b-f424-e053-dadaa90a57ceFormula #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-116-00Hand Sanitizer10 mL in 1 PACKETGEL105
58418-116-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL305
58418-116-02Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL605
58418-116-04Hand Sanitizer120 mL in 1 BOTTLE, PLASTICGEL1205
58418-116-05Hand Sanitizer15 mL in 1 BOTTLE, PLASTICGEL155
58418-116-08Hand Sanitizer240 mL in 1 BOTTLE, PUMPGEL2405
58418-116-09Hand Sanitizer240 mL in 1 BOTTLE, DISPENSINGGEL2405
58418-116-10Hand Sanitizer10 mL in 1 BOTTLE, SPRAYGEL105
58418-116-12Hand Sanitizer360 mL in 1 BOTTLE, PUMPGEL3605
58418-116-15Hand Sanitizer45 mL in 1 BOTTLE, DISPENSINGGEL455
58418-116-16Hand Sanitizer480 mL in 1 BOTTLE, PUMPGEL4805
58418-116-18Hand Sanitizer52 mL in 1 BOTTLE, DISPENSINGGEL525
58418-116-25Hand Sanitizer960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL9600005
58418-116-28Hand Sanitizer840 mL in 1 BOTTLE, PUMPGEL8405
58418-116-32Hand Sanitizer1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12288005
58418-116-55Hand Sanitizer30 mL in 1 BOTTLE, DISPENSINGGEL305
58418-116-64Hand Sanitizer1920 mL in 1 BOTTLE, PUMPGEL19205
58418-116-70Hand Sanitizer211200 mL in 1 DRUMGEL2112005
58418-116-99Hand Sanitizer3840 mL in 1 JUGGEL38405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-116HAND SANITIZER GEL [TROPICAL ENTERPRISES INTERNATIONAL, INC.]5Legacy NDC, 19 package rows20200716_6e013ae7-955c-9d9c-e053-2991aa0a2767.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 1342809Y72KV36IACT
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
9da604db-9825-b2bc-e053-2a95a90a96466e013ae7-955c-9d9c-e053-2991aa0a27672020-02-03WarningsExact identifier
spl id: 9da604db-9825-b2bc-e053-2a95a90a9646
spl set id: 6e013ae7-955c-9d9c-e053-2991aa0a2767

Reported adverse events (FAERS/openFDA)#

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