INSTANT HAND SANITIZER- alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

aloe vera, carbomer, fragrance, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL – 64 fl. oz. bottle

Safetec

NDC: 61010-2111-7

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Citrus

Manufactured by
SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077 www.safetec.com

64 FL. OZ. (1.9 L) Reorder No. 18357

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-2111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	540.26 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
carbomer interpolymer type a (55000 mpa.s) (UNII: 59TL3WG5CO)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-2111-7	1.9 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/10/2012

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-2111)