INSTANT HAND SANITIZER gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Global Protection USA, Inc., Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin without soap and water
• recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

• wet hands thoroughly with product
• allow to dry without wiping
• children under 6 should be supervised while using this product

INACTIVE INGREDIENT

Inactive ingredients aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Distributed by
Global Protection USA, Inc.
West Berlin, NJ 08091
800-957-8955

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE

Global Protection, Inc. “Provider of Homeland Security Equipment”

Instant Hand Sanitizer

Kills 99.9% of Germs

Enriched with Aloe Vera

2 Fl. oz. (59ML)

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50225-355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	60 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
D&C Green no. 5 (UNII: 8J6RDU8L9X)
D&C Yellow no. 10 (UNII: 35SW5USQ3G)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	green (green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50225-355-01	59 mL in 1 BOTTLE
2	NDC: 50225-355-02	236 mL in 1 BOTTLE
3	NDC: 50225-355-03	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	01/06/2010

Labeler - Global Protection USA, Inc. (030123488)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE