Drug Facts

ANTIBACTERIAL HANDSOAP - chloroxylenol gel
Cintas Corp.

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.

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Active ingredient

Chloroxylenol 1.0%

Uses

For hand washing to decrease bacteria on the skin

Recommended for repeated use

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Wet hands.

Apply product and work into a lathers.

Rinse well and dry hands thoroughly.

Inactive Ingredients:

Water, Propylene glycol, Ammonium lauryl sulfate, Ammonium laureth sulfate, Tetrasodium EDTA, Sodium chloride, Glycerin, Citric acid.

Sanis

Antibacterial Gel

Hand

Soap

NSF REGISTERED

1000 ML 33.8 FL OZ

container label

Purpose

Antimicrobial

ANTIBACTERIAL HANDSOAP
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42961-008
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
Water
Propylene Glycol
Ammonium Lauryl Sulfate
Sodium Chloride
Glycerin
Citric Acid Monohydrate
EDETATE SODIUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:42961-008-01	400 mL in 1 BOTTLE, PLASTIC	None
2	NDC:42961-008-03	1000 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/03/2010

Labeler - Cintas Corp. (056481716)

Establishment
Name	Address	ID/FEI	Operations
Natural Essentials		947484713	manufacture

Establishment
Name	Address	ID/FEI	Operations
Camco Chemicals Company Inc		004238366	manufacture

Revised: 11/2011 Cintas Corp.