Drug Labeling and Warnings

Drug Details

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ANTISEPTIC HAND CLEANER- 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 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

Principal Display Panel - 3.79 Liters Container Label
ANTISEPTIC HAND CLEANER 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64009-336
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64009-336-853.79 L in 1 CONTAINER; Type 0: Not a Combination Product
2NDC: 64009-336-90208.20 L in 1 CONTAINER; Type 0: Not a Combination Product
3NDC: 64009-336-9118.95 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(64009-336) , LABEL(64009-336)

Revised: 12/2014
 
Spartan Chemical Company


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