IRIS ANTIMICROBIAL HAND- chloroxylenol soap

Iris Antimicrobial Hand by

Drug Labeling and Warnings

Iris Antimicrobial Hand by is a Otc medication manufactured, distributed, or labeled by Amerifoods Trading Company, Genlabs Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

IRIS ANTIMICROBIAL HAND 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61504-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61504-000-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2013
2	NDC: 61504-000-02	1890 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/18/2013

Labeler - Amerifoods Trading Company (626388680)

Establishment
Name	Address	ID/FEI	Business Operations
Genlabs Corporation		064594260	manufacture(61504-000)