KSS CLEAN HANDS ANTISEPTIC CLEANER- chloroxylenol liquid

KSS CLEAN HANDS ANTISEPTIC CLEANER by

Drug Labeling and Warnings

KSS CLEAN HANDS ANTISEPTIC CLEANER by is a Otc medication manufactured, distributed, or labeled by KSS Enterprises, Canberra Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

KSS CLEAN HANDS ANTISEPTIC CLEANER 
chloroxylenol liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - KSS Enterprises (017173279)

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