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, 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 whenever soap and water handwashing is not readily available
• helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
• recommended for repeated use

Warnings

For external use only. Flammable, keep away from fire or flame

When using this product

• do not get into eyes. If contact occurs, rinse eyes 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 swallowed, get medical help or contact a Poison Control Center right away

Directions

• place a small amount into one hand
• spread over both hands and wrist
• rub into the skin until dry
• do not wipe off; no rinsing required

Inactive ingredients

Aloe vera, carbomer, D&C green #5, D&C yellow#10, fragrance, purified water, triethanolamine

Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label

NDC: 61010-1112-4

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

34,688 fl.oz. (1,026 L) Reorder No. 17382

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-1112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	665 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-1112-4	1026 L in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 61010-1112-7	208.2 L in 1 CONTAINER; Type 0: Not a Combination Product	10/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/16/2010

Labeler - Safetec of America (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-1112)