HAND SANITIZER- benzalkonium chloride liquid

Hand Sanitizer by

Drug Labeling and Warnings

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

Benzalkonium Chloride 0.39%

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 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, propylene glycol, fragrance, purified water, germaben II, ganex p-904 LC

Distributed by:

Distribuido por:      Distribuépar:
HENRY SCHEIN, Inc.

135 Duryea Road
Melville, NY 11747 USA

Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label

Henry Schein

Hand Sanitizer

Mountain Meadow

Jabón higiénico
de manos

Désinfectant pour
les mains

Foaming

Alcohol Free

1.7 fl. oz. (50 ml)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-4445
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	7.49 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-4445-01	0.05 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 0404-4445-02	0.55 L in 1 BOTTLE, PUMP; 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	01/30/2013

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-4445)