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Hand Sanitizer by Henry Schein, Inc.

Dosage form: liquid
Ingredients: benzalkonium chloride 7.49g in 1L
Labeler: Henry Schein, Inc.
NDC Code: 0404-4445

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.

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)

HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-4445
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride7.49 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
water 
aloe vera leaf 
propylene glycol 
diazolidinyl urea 
Packaging
#Item CodePackage Description
1NDC:0404-4445-010.05 L in 1 BOTTLE, PUMP
2NDC:0404-4445-020.55 L in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/30/2013
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(0404-4445)

Revised: 01/2013
 
Henry Schein, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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