ALCOHOL AGENT SANITIZER- hand sanitizer and agent spray spray

Alcohol Agent Sanitizer by

Drug Labeling and Warnings

Alcohol Agent Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Ethyl Alcohol 70% v/v

ASK DOCTOR

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Uses: For handwashing to decrease bacteria on the skin.

QUESTIONS

Questions: 855-647-4647

STOP USE

WHEN USING

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

WARNINGS

WARNINGS For external use only

SAFE HANDLING WARNING

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

OTHER SAFETY INFORMATION

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

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL AGENT SANITIZER 
hand sanitizer and agent spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	20.4 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-159-20	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2021

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Enterprises International, Inc.		091986179	manufacture(58418-159) , label(58418-159) , pack(58418-159)