IRIS ANTIMICROBIAL HAND- chloroxylenol soap 
Amerifoods Trading 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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Iris Antimicrobial Hand Soap

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antimicrobial

Uses

  • Antimicrobial hand soap

Warnings

For external use only

When using this product

  • do not use in or near eyes

Keep out of reach of children. In case of accidental ingestion, seek medical
attention or contact a poison control center immediately.

Directions

• wet hands • dispense a small amount of soap into the palm of
the hand • work up a lather, adding water as needed • rinse

Other information

• store at room temperature

Inactive ingredients:

5-Chloro-2-Methyl-4-Isothiazolin-3-One,
Cocamide MIPA, Cocamidopropyl Betaines, FD&C Red #40, FD&C Yellow #5,
Fragrance, Glycerin, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride,
Sodium Lauryl Sulfate, Water.

Package Label

Kills 99%
Germs Instantly

Iris
Antimicrobial Hand Soap

CAUTION: KEEP OUT OF REACH OF CHILDREN.
SEE BACK PANEL FOR ADDITIONAL PRECAUTIONS.

16 FL OZ
(1 PINT) 473 mL

For medical emergency information
please call 1-800-424-9300
For MSDS call 1-800-427-3443 x 7600

DISTRIBUTED BY: AMERIFOODS TRADING CO.
P.O. BOX 512377, LOS ANGELES, CA 90051-0377
PRODUCT OF U.S.A.

Front LabelBack Label


IRIS ANTIMICROBIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61504-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLCHLOROISOTHIAZOLINONE 
COCO MONOISOPROPANOLAMIDE 
COCAMIDOPROPYL BETAINE 
GLYCERIN 
METHYLISOTHIAZOLINONE 
SODIUM CHLORIDE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61504-000-01473 mL in 1 BOTTLE
2NDC:61504-000-021890 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/18/2013
Labeler - Amerifoods Trading Company (626388680)
Establishment
NameAddressID/FEIBusiness Operations
Genlabs Corporation064594260manufacture(61504-000)

Revised: 12/2013
Document Id: bea728e3-5d01-426d-b561-3116cc73f7fd
Set id: 24bdb15d-91bb-43ff-b420-a5e7f97fbd6d
Version: 1
Effective Time: 20131218
 
Amerifoods Trading Company