NDC Code(s) : 64009-336-85, 64009-336-90, 64009-336-91
Packager : Spartan Chemical Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Antiseptic Hand CleanerChloroxylenol SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64009-336
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL10.11 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
1NDC:64009-336-853.79 L in 1 CONTAINER Type 0: Not a Combination Product15/01/2015
2NDC:64009-336-90208.2 L in 1 CONTAINER Type 0: Not a Combination Product15/01/2015
3NDC:64009-336-9118.95 L in 1 CONTAINER Type 0: Not a Combination Product15/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 01/05/2015

LABELER - Spartan Chemical Company(005036728)

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

PRINCIPAL DISPLAY PANEL

Spartan ®

ANTISEPTIC

HAND CLEANER TM

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

antiseptic