ANTISEPTIC HAND CLEANER- chloroxylenol soap

Antiseptic Hand Cleaner by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Chloroxylenol 1.0%

Purpose

Antiseptic handwash

Uses

• For hand washing 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 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.
• Apply a small amount of product (about 5 ml) on 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, Sodium Chloride, Fragrance, Styrene/Acrylamide Copolymer, Trisodium Dicarboxymethyl Alaninate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Yellow No. 5, FD&C Green No. 3

Questions?

1-800-537-8990

Principal Display Panel - 3.79 Liters Container Label

Spartan®

ANTISEPTIC

HAND CLEANERTM

Germ-fighting formula that meets the hand care needs
of institutional and industrial personnel Contains 1.0% Chloroxylenol.

Helps decrease bacteria on hands.

FOR INSTITUTIONAL AND INDUSTRIAL USE ONLY

Formula para combatir microbios que satisface las necesidades
de cuidar las manos del personal institucional e industrial. Contiene
1.0% Cloroxilenol. Ayuda a disminuir las bacterias en las manos.

PARA USO INSTITUCIONAL E INDUSTRIAL SOLAMENTE

Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA

NET CONTENTS: 1 U.S. Gallon/3.79 Liters

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

#3043

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND CLEANER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64009-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	10.11 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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)
Sodium Chloride (UNII: 451W47IQ8X)
Styrene/Acrylamide Copolymer (MW 500000) (UNII: 5Z4DPO246A)
Trisodium Dicarboxymethyl Alaninate, L- (UNII: L754QR50CZ)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C Green No. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64009-336-85	3.79 L in 1 CONTAINER; Type 0: Not a Combination Product	01/15/2015
2	NDC: 64009-336-90	208.20 L in 1 CONTAINER; Type 0: Not a Combination Product	01/15/2015
3	NDC: 64009-336-91	18.95 L in 1 CONTAINER; Type 0: Not a Combination Product	01/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2015

Labeler - Spartan Chemical Company (005036728)

Establishment
Name	Address	ID/FEI	Business Operations
Spartan Chemical Company		005036728	MANUFACTURE(64009-336) , LABEL(64009-336)