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 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 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 & wrists thoroughly with product and allow to dry without wiping
• children under 6 years of age 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

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

Instant

Hand

Sanitizer

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – Box Label

NDC: 61010-1112-2

Safetec

Infection Control

Instant Hand Sanitizer

Fresh Scent Instant Hand

Sanitizer with Aloe Vera

25 Packets

Each Packet Net. Wt. 0.9gm

PRINCIPAL DISPLAY PANEL – 10 Packet Box Label

Safetec®

INSTANT
Hand Sanitizer

Fresh scent instant hand sanitizer
with moisturizing Aloe Vera

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 17395

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: 61010-1112-2	25 in 1 BOX	12/15/2010
1	NDC: 61010-1112-1	0.034 L in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 61010-1112-3	144 in 1 BOX	12/15/2010
2	NDC: 61010-1112-1	0.034 L in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 61010-1112-8	10 in 1 BOX	04/01/2020
3	NDC: 61010-1112-1	0.034 L in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/15/2010

Labeler - Safetec of America (874965262)

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