INSTANT HAND SANITIZER- alcohol gel
Safetec of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on skin without soap and water

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 develops 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 and rub over both hands & wrists until dry
allow to dry without wiping
children under 6 should be supervised while using this product

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 – 800 ML Box Label

NDC 61010-1111-5

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with Aloe Vera

Fresh Scent

27.05 FL. OZ. (800 ML)

Reorder No. 17360

PRINCIPAL DISPLAY PANEL – 800 ML Box Label

PRINCIPAL DISPLAY PANEL – 1000 ML Box Label

NDC 61010-1111-9

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with Aloe Vera

Fresh Scent

33.81 FL. OZ. (1000 ML)

Reorder No. 17375

PRINCIPAL DISPLAY PANEL – 1000 ML Box Label

INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-1111
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (alcohol)	alcohol	665 mL in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf
carbomer interpolymer type a (55000 mpa.s)
d&c green no. 5
d&c yellow no. 10
water
trolamine

Packaging
#	Item Code	Package Description
1	NDC:61010-1111-5	0.8 L in 1 BOX
2	NDC:61010-1111-9	1.0 L in 1 BOX

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, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-1111)

Revised: 05/2012

Document Id: 6b59d689-0b82-45cb-886e-ae2794d3fd2a

Set id: 016f9770-3dd5-4480-a687-f9bb2ea73e86

Version: 2

Effective Time: 20120510

Safetec of America, Inc.