HAND-GIENE 367 - chloroxylenol soap
Whisk Products, 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.

----------

Active Ingredient
Chloroxylenol 1% w/w

Purpose
Skin Antimicrobial

Use
reduces amount of bacteria on hands

Warnings
For external use only. Do not use in eyes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician.
Not for use on children under six months of age.
For institutional and professional use only.

Directions

Wet hands and forearms.
Apply a small amount (5 mL) or palmful to hands and forearms.
Scrub thoroughly for at least 15 seconds.
Rinse completely and dry.

Inactive Ingredients
Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

HAND-GIENE 367
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-487
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (Chloroxylenol)	Chloroxylenol	1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water
Propylene Glycol
TROLAMINE LAURYL SULFATE
LAURIC DIETHANOLAMIDE
DMDM HYDANTOIN
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics
Color	green (green, dispensed as white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:65585-487-07	4 BOTTLE, PUMP ( BOTTLE) in 1 BOX	contains a BOTTLE, PUMP
1		1750 g in 1 BOTTLE, PUMP	This package is contained within the BOX (65585-487-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2006	12/31/2008

Labeler - Whisk Products, Inc. (834270639)

Establishment
Name	Address	ID/FEI	Operations
Whisk Products, Inc.		834270639	manufacture

Revised: 12/2011 Whisk Products, Inc.