Drug Labeling and Warnings

Drug Details

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LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH- chloroxylenol 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.

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Drug Facts

Active Ingredients

Chloroxylenol 1.0%

Purpose

Antiseptic

Uses

  • Healthcare personnel hand wash for hand washing to decrease bacteria on the skin before and after contact with a person under medical care or treatment.
  • 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 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

  • Wet hands and forearms.
  • Pump enough foam into your palm to thoroughly cover your hands.
  • Scrub thoroughly for at least 20 seconds.
  • Rinse well and dry hands completely.

Inactive Ingredients

Water, Cetrimonium Chloride, Cocamine, Glycerin, Lactic Acid, PEG-120 Methyl Glucose Dioleate, Coco Diisopropanolamide, Fragrance, Trisodium Dicarboxymethyl Alaninate, D&C Green No. 8, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Blue No. 1

Questions?

1-800-537-8990

Principal Display Panel - 3.79 Liters Container Label

Spartan®

Lite'nFoamy®

Healthcare Personnel Handwash

Antiseptic Foam Handwash with Fragrance

For hand washing to decrease bacteria on the skin.

FOR HOSPITAL AND PROFESSIONAL USE ONLY

See back panel for additional information.

Producto de Limpieza Antiseptico para Manos

Para lavar las manos para minimizar los microbios sobre la piel.

PARA HOSPITAL Y USO PROFESIONAL

Consulte el panel dorsa para mayor informacion.

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 / CONTENIDO NETO: 3.79 Litros / 1 Galon EE.UU.

#3341

Principal Display Panel - 3.79 Liters Container Label
LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64009-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol10.11 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetrimonium Chloride (UNII: UC9PE95IBP)  
Cocamine (UNII: 6724Q5747W)  
Glycerin (UNII: PDC6A3C0OX)  
Lactic Acid, L- (UNII: F9S9FFU82N)  
PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
Coco Diisopropanolamide (UNII: S485AM948Q)  
Trisodium Dicarboxymethyl Alaninate, L- (UNII: L754QR50CZ)  
D&C Green No. 8 (UNII: I2W85YOX9L)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64009-335-853.79 L in 1 CONTAINER; Type 0: Not a Combination Product
2NDC: 64009-335-820.532 L in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/05/2015
Labeler - Spartan Chemical Company (005036728)
Establishment
NameAddressID/FEIBusiness Operations
Spartan Chemical Company005036728MANUFACTURE(64009-335) , LABEL(64009-335)

Revised: 12/2014
 
Spartan Chemical Company


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