Drug Labeling and Warnings

Drug Details

k">

LITE NFOAMY E3 HAND SANITIZER- benzalkonium chloride soap 
Spartan Chemical Company

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 Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

  • For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develops, or if condition 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

  • Hands must be washed and rinsed with potable water before use.
  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Other Information

  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.

Inactive Ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17-Cocoate, Citric Acid

Questions?

1 -800-537-8990

Principal Display Panel - Container Label

Spartan®

Lite'nFoamy®

E3 Hand Sanitizer

Foam Hand Sanitizer- Fragrance Free

  • Quickly works to reduce the bacteria on the hands in 15 seconds
  • Recommended for use by food service and food processing personnel

FOR INSTITUTIONAL AND INDUSTRIAL USE ONLY

See back panel for additional information.

Manufactured by
Spartan Chemical Company, Inc.

1110 Spartan Drive, Maumee, OH 43537 USA

Medical Emergency: 888-314-6171 / www.spartanchemical.com

Net Contents: 1 U.S. Gallon / 3.79 Liters

Principal Display Panel - Container Label
LITE NFOAMY E3 HAND SANITIZER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64009-334
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.0 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetrimonium chloride (UNII: UC9PE95IBP)  
Laurtrimonium chloride (UNII: A81MSI0FIC)  
Glycereth-17 cocoate (UNII: 3057VPT0KC)  
Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64009-334-053.79 L in 1 CONTAINER
2NDC: 64009-334-08280.20 L in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2014
Labeler - Spartan Chemical Company (005036728)
Establishment
NameAddressID/FEIBusiness Operations
Spartan Chemical Company005036728MANUFACTURE(64009-334) , LABEL(64009-334)

Revised: 3/2014
 
Spartan Chemical Company


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.