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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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Drug Facts

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.

Purpose

Antimicrobial

Sanis

Antibacterial Gel

Hand

Soap

NSF REGISTERED

1000 ML 33.8 FL OZ

container label

container label3

ANTIBACTERIAL HANDSOAP
chloroxylenol gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
Sodium Chloride (UNII: 451W47IQ8X)
Glycerin (UNII: PDC6A3C0OX)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 42961-008-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2010	07/31/2019
2	NDC: 42961-008-08	3 mL in 1 TUBE; Type 0: Not a Combination Product	05/03/2010	07/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/03/2010	07/31/2019

Labeler - Cintas Corp. (056481716)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Essentials		947484713	manufacture(42961-008)

Name	Address	ID/FEI	Business Operations
Establishment
Camco Chemicals Company Inc		004238366	manufacture(42961-008)

Revised: 1/2019

Document Id: 72893931-72fe-4fac-bbbd-246385f80bb9

Set id: f7791f74-3791-4968-937a-1fca119584fe

Version: 7

Effective Time: 20190118

Cintas Corp.

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