SIGNATURE ANTIBACTERIAL FOAMING HAND- benzalkonium chloride liquid

Signature Antibacterial Foaming Hand by

Drug Labeling and Warnings

Signature Antibacterial Foaming Hand by is a Otc medication manufactured, distributed, or labeled by Cintas Corp., Best Sanitizers, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.12%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on skin

Recommended for repeated use

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions:

Wet hands.

Apply product and work into a lather.

Rinse well and dry hands thoroughly.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Glycerine, Cocamidopropyl betaine, Polyethylene-polypropylene glycol, Benzyl alcohol, Phenoxyethanol, Tetrasodium EDTA, Dehydroacetic acid

PRINCIPAL DISPLAY PANEL

Cintas

Signature Series

Antibacterial Foaming Hand Soap

500 ML/16.9 FL OZ

INGREDIENTS AND APPEARANCE

SIGNATURE ANTIBACTERIAL FOAMING HAND  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-011-05	500 mL in 1 BAG
2	NDC: 42961-011-06	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/10/2014

Labeler - Cintas Corp. (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers, Inc		627278224	manufacture(42961-011)