KSS CLEAN HANDS ANTISEPTIC CLEANER- chloroxylenol liquid
KSS Enterprises

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.

----------

CLEAN HANDS ANTISEPTIC

Drug Facts

Active Ingredient

Chloroxylenol (1% v/v)

Purpose

Antiseptic Hand Cleanser

Uses

Helps reduce bacteria that potentially can cause disease
Helps prevent cross contamination by hand contact

Warnings

For external use only
Do not use near eyes
Keep out of reach of children.
In case of eye contact flush with water for 15 minutes
If irritation persists, get medical attention
In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

Wet hands and forearms
Apply appropriate amount to palm and hand
Scrub hands and forearms for 60 seconds
Rinse well
Wipe dry with towel, repeat if necessary.

Other Information

Assists with OSHA bloodborne pathogen standard compliance

Inactive Ingredients

Water, Cocoate, Oleate, Cocamidopropyl betaine, Hydroxyethyl Cellulose, Polyquaternium 7, Na4EDTA, 2-Propanol, Peg-75 Lanolin, Aloe Vera Gel, Fragrance, Triclosan, DMDM Hydantoin.

Principal Display Panel – Bottle Label

KSS

CLEAN HANDS ANTISEPTIC

Antiseptic Lotion Cleaner

A Powerful Antiseptic Cleanser for Handwashing Enhanced With Moisturizers

Reduces Bacteria on Skin That Can Potentially Cause Disease
Assists with OSHA Bloodborne Pathogen Standard Compliance

See Drug Facts panel for additional information.

KSS CLEAN HANDS ANTISEPTIC CLEANER
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29991-505
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q)	chloroxylenol	10.22 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
potassium oleate (UNII: 74WHF607EU)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
hydroxyethyl cellulose (2000 CPS at 1%) (UNII: S38J6RZN16)
isopropyl alcohol (UNII: ND2M416302)
edetate sodium (UNII: MP1J8420LU)
aloe vera leaf (UNII: ZY81Z83H0X)
DMDM hydantoin (UNII: BYR0546TOW)
triclosan (UNII: 4NM5039Y5X)
potassium cocoate (UNII: F8U72V8ZXP)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:29991-505-05	3785 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	06/01/2007

Labeler - KSS Enterprises (017173279)

Name	Address	ID/FEI	Business Operations
Establishment
Canberra Corporation		068080621	MANUFACTURE