ANTIBACTERIAL SKIN CLEANSER 82 - antibacterial hand soap soap
Penco 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
Health Care Personnel Hand Wash

Uses

Hand Wash to help reduce bacteria that cause disease
Repeated usage suggested

Warnings
For external use only.
Keep out of reach of children.
Avoid contact with eyes and mouth.
If redness or irritation develops, discontinue use immediately. If condition persists for more than 72 hours, consult a physician.
Not for use on children under 6 months of age.

Directions

Wash hands and forearms.
Apply 5 mL of product to hands.
Scrub well for 30 seconds.
Rinse and repeat.

Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid

In Case of Emergency
Call: (800) 228-5635 ext. 167

ANTIBACTERIAL SKIN CLEANSER 82
antibacterial hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42497-822
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Isopropyl Alcohol (UNII: ND2M416302)
Edetate Sodium (UNII: MP1J8420LU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Lauric Diethanolamide (UNII: I29I2VHG38)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)

Product Characteristics
Color	white (opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42497-822-14	503 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	03/04/2010

Labeler - Penco Products, Inc. (808679773)