KE-53PS HAND SANITIZER- ethanol gel

KE-53PS Hand Sanitizer by

Drug Labeling and Warnings

KE-53PS Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kinzua Environmental Inc. , Canberra Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient:

Ethanol (60% v/v)

Purpose:

Anti-Microbial Hand Sanitizer

Uses

• Helps reduce bacteria that potentially can cause disease
• Helps prevent cross contamination by hand contact
• Recommended for repeated use

Warnings

• For external use only
• Flammable, keep away from fire, heat, or flame
• Keep out of reach of children.
• Do not use near eyes
• In case of eye contact flush with water for 15 minutes
• If irritation persists stop use of product and get medical attention
• In case of accidental ingestion seek medical attention or contact a poison control center immediately.

Directions

• Use no water or towels
• Apply appropriate amount of product to palm of hand
• Rub until hands are completely covered
• Agitate lightly until dry
• Let air dry for 15 seconds
• Do not rinse or wipe with towel.

Other Information

• Store in a cool dry place below 104° F.

Inactive Ingredients

Water, Carbomer, Triethanolamine, PEG-75 Lanolin, Aloe Vera Gel, Fragrance.

Principal Display Panel

Principal Display Panel – Bottle Label

KE-53PS
Gel Hand Sanitizer

• Enhanced with Moisturizers
• Kills disease causing germs within seconds
• Effective against MRSA, VRE, E. coli (0157:H7) Staphylococcus, Streptococcus and other organisms
• Assists with OSHA Bloodborne Pathogen Standard Compliance

For Hospital and Professional Use Only
See Drug Facts panel for additional information

12-266-1362
Manufactured for:
KINZUA ENVIRONMENTAL, Inc.
1176 E. 38th. CLEVELAND, OH 44114
1-800-233-5079

INGREDIENTS AND APPEARANCE

KE-53PS HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64121-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ethanol (UNII: 3K9958V90M) (ethanol - UNII:3K9958V90M)	ethanol	600 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
carbomer homopolymer type C (UNII: 4Q93RCW27E)
aloe (UNII: V5VD430YW9)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64121-515-27	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	05/21/2010

Labeler - Kinzua Environmental Inc. (612966374)

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