CLEAN CHOICE ANTIBACTERIAL- chloroxylenol liquid 
Deb USA, Inc.

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 ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

avoid contact with eyes.  In case of eye contact, flush with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply foaming cleanser to dry hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse & dry hands thoroughly

Inactive ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Magnesium Nitrate, Propylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

Clean Choice Antibacterial Foam Soap

1L

33.8 fl. oz.

Part #0617376

Distributed by Fastenal Co.

Winona, MN 55987

2013 fastenal.com

Made in U.S.A.

0617376

Antibacterial Foam Soap

Rev. 08-13-116

product label front

product label back

CLEAN CHOICE ANTIBACTERIAL 
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-232
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 5 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11084-232-27 1000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/15/2013
Labeler - Deb USA, Inc. (607378015)
Establishment
Name Address ID/FEI Business Operations
Deb USA, Inc. 607378015 manufacture(11084-232)

Revised: 9/2013
Document Id: ee9fe4cf-db6d-4439-b6f3-8f2a967acee4
Set id: 092a9e0e-113b-4515-9871-b2aa7bea28b4
Version: 1
Effective Time: 20130912
 
Deb USA, Inc.