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

Safetec of America, Inc.

Instant Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

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

Do not use in the eyes. If this happens, rinse thoroughly with water

STOP USE

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

Supplied by

STATINA

HEALTHCARE AUSTRALIA

3/12 Yatala Rd.

Mt. Kuring-Gai, NSW, 2080

1300 365 404

www.statina.com.au

PRINCIPAL DISPLAY PANEL

NDC: 61010-4111-0

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

16 FL. OZ. (473 ML)

Reorder No. 17358

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

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

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

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: 61010-4111-0	473 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/15/2010

Labeler - Safetec of America (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE