HAND SANITIZER WITH ADDITIVE gel

Hand Sanitizer with Additive by

Drug Labeling and Warnings

Hand Sanitizer with Additive 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 prompy medical attention.

PURPOSE

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

QUESTIONS

Questions: 1-800-535-5053

STOP USE

WHEN USING

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive Ingredients: Silicon Quaternary Ammonia Salt .75%, Water, Carbomer, Triethanolamine

WARNINGS

WARNINGS: For external use only

SAFE HANDLING WARNING

Flammable: Keep away from open flame. Avoid freezing and excessive heat about 40C.

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

HAND SANITIZER WITH ADDITIVE 
hand sanitizer with additive gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-119
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)
CARBOMER 1342 (UNII: 809Y72KV36)
TROLAMINE (UNII: 9O3K93S3TK)
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-119-08	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020
2	NDC: 58418-119-64	3840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)