SPARTAN ANTISEPTIC HAND CLEANER- chloroxylenol soap

Spartan Antiseptic Hand Cleaner by

Drug Labeling and Warnings

Spartan Antiseptic Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by Spartan Chemical Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Chloroxylenol 1% w/w

Purpose

Health-care personnel handwash

Uses:

• Handwash to help reduce bacteria which can potentially cause disease.
• Recommended for repeated use.

Warnings:

• For external use only.
• Do not use in eyes.
• Discontinue use if irritaiton and redness develop.  If condition persists for more than 72 hours consult a doctor.

• Keep out of reach of children.
• Do not use on children under 6 months of age.

Directions:

• Wet hands and forearms.
• Apply 5 mls. or palmful of product to hands and forearms.
• Scrub thoroughly for 30 seconds.
• Rinse and repeat.

INACTIVE INGREDIENT

Water, Lauramide DEA, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Polyquaternium-7, Styrene Acrylates Copolymer, Isopropanol, Fragrance, Tetrasodium EDTA, Citric Acid, FD&C Green #3, FD&C Yellow #5

Questions?

Phone# 1-800-537-8990

DESCRIPTION

This synergistic blend of surfactants is pH balanced and mild to the skin.  Germ-fighting formula that meets the hand care needs of institutional and industrial personnel!  Contains 1% Chloroxylenol.  Helps reduce bacteria on hands.

Esta mezcla de surfactantes sinérgica tiene pH balanceado y está suave a la piel.  ¡Formula para combatir micorbios que satisface las necesidades de cuidar las manos del personal institucional e industrial!  Contiene 1% cloroxilenol.  Ayuda a reducir bacteria sobre las manos.

Distrbuted by: Distribuido por:

SPARTAN CHEMICAL COMPANY, INC., 1110 Spartan Drive, Maumee, Ohio 43537

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPARTAN ANTISEPTIC HAND CLEANER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64009-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	10.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	green (light green, opaque liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64009-360-01	3785 mL in 1 BOTTLE, PLASTIC
2	NDC: 64009-360-06	208198 mL in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/18/2013

Labeler - Spartan Chemical Company, Inc. (005036728)