Formula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2020-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:30

Label at a glance#

ProductHS
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Uses : Hand Sanitizer to 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

Active Ingredient

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose..... Antiseptic

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses: Hand Sanitizer to reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

updated Use:

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.

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

WARNING

WARNINGS SECTION

WARNINGS: For external use only. When using this product avoid contact with eyes. If

contact with eyes occurs, flush with water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or redness develops and persists.

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.

SAFE HANDLING WARNING SECTION

Flammable. Keep away from open flames.

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

OTC - QUESTIONS SECTION

Questions: 1-800-535-5053

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml30ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-156-012022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-022022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-042022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-052022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-082022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-102022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-122022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-162022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-252022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-282022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-322022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-642022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-702022-01-28C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-012020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-022020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-042020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-052020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-082020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-102020-07-16C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-012020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-022020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-042020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-052020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-082020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula
58418-156-102020-01-31C16284748780-19d75b9d1-126f-f424-e053-dadaa90a57ceFormula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray Iceus formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-156-01HS30 mL in 1 BOTTLE, SPRAYSPRAY302
58418-156-02HS60 mL in 1 BOTTLE, SPRAYSPRAY602
58418-156-04HS120 mL in 1 BOTTLE, SPRAYSPRAY1202
58418-156-05HS15 mL in 1 BOTTLE, SPRAYSPRAY152
58418-156-08HS240 mL in 1 BOTTLE, PUMPSPRAY2402
58418-156-10HS10 mL in 1 BOTTLE, SPRAYSPRAY102
58418-156-12HS360 mL in 1 BOTTLE, PUMPSPRAY3602
58418-156-16HS480 mL in 1 BOTTLE, PUMPSPRAY4802
58418-156-25HS960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSPRAY9600002
58418-156-28HS3840 mL in 1 JUGSPRAY38402
58418-156-32HS1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSPRAY12288002
58418-156-64HS1920 mL in 1 BOTTLE, PUMPSPRAY19202
58418-156-70HS211200 mL in 1 DRUMSPRAY2112002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-156HS (HAND SANITIZER SPRAY) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.]2Legacy NDC, 13 package rows20200716_70ab7b6e-5a6e-7ab2-e053-2a91aa0ab9c8.zip

Products#

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

DailyMed product names page 1 of 1 · 6 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.

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
9da4ec9a-4c0c-f000-e053-2995a90a69f070ab7b6e-5a6e-7ab2-e053-2a91aa0ab9c82020-02-02WarningsExact identifier
spl id: 9da4ec9a-4c0c-f000-e053-2995a90a69f0
spl set id: 70ab7b6e-5a6e-7ab2-e053-2a91aa0ab9c8

Reported adverse events (FAERS/openFDA)#

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