HAND SANITIZER- benzalkonium chloride liquid 
Henry Schein, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.39%

Purpose

Antiseptic

Uses

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

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)

PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label
HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-4445
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 1/2013
Document Id: 1a133c7c-aba0-4011-8213-3d889737d502
Set id: f515a055-285a-46dc-8649-0fd2c2930e05
Version: 2
Effective Time: 20130130
 
Henry Schein, Inc.