Alcohol Agent Sanitizer

Manufacturer: Tropical Enterprises International, Inc.
Effective date: 2020-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:36:21

Label at a glance#

ProductAlcohol Agent Sanitizer

Active ingredientALCOHOL

Label structure14 sections

Contacts and useful links#

PhoneLabel contact855-647-4647

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Ethyl Alcohol 70% v/v

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Uses: For handwashing to decrease bacteria on the skin.

OTC - QUESTIONS SECTION

Questions: 855-647-4647

OTC - STOP USE SECTION

STOP USE SECTION

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT SECTION

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, 3-(Trihydroxysilyl)propyldimethyloctadecyl ammonium chloride

WARNINGS SECTION

WARNINGS For external use only

SAFE HANDLING WARNING SECTION

Flammable. Keep away from open flame. Do not store above 110F.

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE SECTION

Uses: For handwashing to decrease bacteria on the skin.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58418-159-20	2022-01-28	C162847	48780-1	d6a99b39-81dc-a426-e053-dadaa90af4c2	Formula # SC-077 70% Ethyl Alcohol Hand Sanitizer Spray with Spar additive.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58418-159-20	Alcohol Agent Sanitizer	20 mL in 1 BOTTLE, SPRAY	SPRAY	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58418-159	ALCOHOL AGENT SANITIZER (HAND SANITIZER AND AGENT SPRAY) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.]	1	Legacy NDC, 1 package rows	20210101_b7c9f235-f861-4def-e053-2a95a90a41c9.zip

Products#

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

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

Alcohol Agent Sanitizer
Hand Sanitizer and Agent Spray
WATER
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58418-159	58418-159-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE	GLJ50K866T	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b7c9f235-f862-4def-e053-2a95a90a41c9			b7c9f235-f861-4def-e053-2a95a90a41c9	2020-12-31	Warnings	Exact identifier spl id: b7c9f235-f862-4def-e053-2a95a90a41c9 spl set id: b7c9f235-f861-4def-e053-2a95a90a41c9

Reported adverse events (FAERS/openFDA)#

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