Drug Facts

Active Ingredient

Ethyl Alcohol 70%

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 61010-4111-1

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

34,688 fl.oz. (1,026 L) Reorder No. 17392

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

INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-4111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61010-4111-1	1026000 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/16/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	12/16/2010

Labeler - Safetec of America, Inc. (874965262)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	manufacture(61010-4111)

NDC 61010-4111-1, Instant Hand Sanitizer-alcohol gel