Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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 linoleammonium chloride, PEG-4 rapeseedamide, Dihydroxyethyl cocamine oxide, Fragrance, DMDM hydantoin, Citric acid, FDC Red 4

Sanis

Antibacterial

Foaming

Hand Soap

800 ml 27.0 FL OZ

ANTIBACTERIAL FOAMING HAND  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-001-02	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2008	07/31/2019
2	NDC: 42961-001-06	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2008	07/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2008	07/31/2019

Labeler - Cintas Corp. (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials		947484713	manufacture(42961-001)

Establishment
Name	Address	ID/FEI	Business Operations
Camco Chemicals Company Inc		004238366	manufacture(42961-001)

Establishment
Name	Address	ID/FEI	Business Operations
Avmor		202107827	manufacture(42961-001)

Revised: 1/2019

Document Id: c8ccd1af-0d35-49c9-b4d3-38d1e84ee66d

34390-5

Set id: a8532525-4bc4-4103-bd61-605aeeed47bb

Version: 8

Effective Time: 20190118

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