SIGNATURE ANTIBACTERIAL FOAMING HAND - benzalkonium chloride liquid
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

Benzalkonium Chloride 0.125%

Purpose

Antimicrobial

Uses

For hand sanitizing 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 eyes 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 lather.

Rinse well and dry hands thoroughly.

Inactive Ingredients:

Water, Cocamidopropylamine oxide, Dihydroxypropyl PEG 5 linoleammmonium chloride, PEG-4 rapeseedamide, Dihydroxyethyl cocamine oxide, DMDM hydantoin, Citric acid

Cintas

Signature Series

Antibacterial Foaming Hand Soap

500 ML/16.9 FL OZ

container label

SIGNATURE ANTIBACTERIAL FOAMING HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42961-010
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42961-010-05	500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/09/2013	03/09/2016

Labeler - Cintas Corp. (056481716)

Name	Address	ID/FEI	Business Operations
Establishment
Avmor		202107827	manufacture(42961-010)

Revised: 3/2016

Document Id: 6759c99d-eb0f-44d8-ae5c-2ec6e0a739b8

Set id: 1845e685-8c50-450d-8e2b-38d255dcd0d9

Version: 2

Effective Time: 20160309

Cintas Corp.