Hand Sanitizer by Tropical Enterprises International, Inc. HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand 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

DOSAGE AND ADMINISTRATION

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

INACTIVE INGREDIENT

InActive Ingredients: Water, Carbomer, Triethanolamine

INDICATIONS AND USAGE

Uses: For handwashing to decrease bacteria on the skin

KEEP OUT OF REACH OF CHILDREN

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

OTC PURPOSE

Purpose... Antiseptic

WARNING

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)
CARBOMER 1342 (UNII: 809Y72KV36)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-116-00	10 mL in 1 PACKET; Type 0: Not a Combination Product	08/01/2012
2	NDC: 58418-116-05	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2012
3	NDC: 58418-116-10	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2012
4	NDC: 58418-116-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2012
5	NDC: 58418-116-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2012
6	NDC: 58418-116-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2012
7	NDC: 58418-116-08	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
8	NDC: 58418-116-12	360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
9	NDC: 58418-116-16	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
10	NDC: 58418-116-64	1920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012
11	NDC: 58418-116-28	840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2012

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)