Your browser does not support JavaScript! HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN, INC.]
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HAND SANITIZER (benzalkonium chloride) liquid
[Henry Schein, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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

2 fl. oz. (50 ml)

PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label
HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0404-4445)

Revised: 1/2013
 
Henry Schein, Inc.

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