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 Henry Schein, Inc., 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

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, fragrance, purified water, triethanolamine

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA
Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

Henry Schein

112-5991

Maxiclens

Instant Hand Sanitizer

NDC: 0404-5991-01

27.05 FL. OZ. (800 ML)

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-5991
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	665 mL  in 1000 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: 0404-5991-01	800 mL in 1 BOX; Type 0: Not a Combination Product	02/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2012

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-5991)