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]

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin
• 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 ingredients

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

PRINCIPAL DISPLAY PANEL – 1.9 L Bottle Label

NDC: 61010-1111-7

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Fresh

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

64 FL. OZ. (1.9 L) Reorder No. 17357

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. box

NDC: 61010-1111-8

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs
Enriched with Aloe Vera

Fresh Scent

0.0570 FL. OZ. (1.68 ML) packets
100 packets per box

Reorder No. 17353

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

PRINCIPAL DISPLAY PANEL – 0.0570 fl. oz. packet

NDC: 61010-1111-8

Safetec

instant

Hand

Sanitizer

Fresh Scent

0.0570 fl.oz.
(1.68 ML)

Reorder No. 17353

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

Principal Display Panel – 2.0 FL OZ Bottle Panel

NDC: 61010-1111-0

Safetec

A.B.H.C.™ MEETS CDC HANDWASHING RECOMMENDATIONS

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Fresh

2.0 FL. OZ. (59 ML)

Principal Display Panel – 4.0 FL OZ Bottle Panel

NDC: 61010-1111-1

Safetec

A.B.H.C.™ MEETS CDC HANDWASHING RECOMMENDATIONS

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Fresh

4.0 FL. OZ. (118 ML)

Principal Display Panel – 8.0 FL OZ Bottle Panel

Safetec

A.B.H.C.™ MEETS CDC HANDWASHING RECOMMENDATIONS

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Fresh

8.0 FL. OZ. (237 ML)

Principal Display Panel – 16.0 FL OZ Bottle Panel

NDC: 61010-1111-4

Safetec

A.B.H.C.™ MEETS CDC HANDWASHING RECOMMENDATIONS

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Fresh

16.0 FL. OZ. (473 ML)

Reorder No. 17354

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-1111
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 (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-1111-7	1.9 L in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2010
2	NDC: 61010-1111-5	0.8 L in 1 BOX; Type 0: Not a Combination Product	12/16/2010
3	NDC: 61010-1111-9	1.0 L in 1 BOX; Type 0: Not a Combination Product	12/16/2010
4	NDC: 61010-1111-3	100 in 1 BOX	12/16/2010
4		0.0037 L in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 61010-1111-8	100 in 1 BOX	12/16/2010
5		0.00168 L in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 61010-1111-0	0.059 L in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2010
7	NDC: 61010-1111-1	0.118 L in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2010
8	NDC: 61010-1111-6	0.237 L in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2010
9	NDC: 61010-1111-4	0.473 L in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2010

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)