Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

FOAMING HAND SANITIZER - 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 0.1%

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:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

Inactive Ingredients:

Cetrimonium Chloride, Citric Acid, Dihydroxyethyl Cocamine Oxide, Fragrance, Glycereth-17 Cocoate, Laurtrimonium Chloride, Water

Sanis

Foaming

Hand

Sanitizer

800ML 27.0 FL OZ

FOAMING HAND SANITIZER  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-009
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-009-02	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2013	07/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2013	07/31/2019

Labeler - Cintas Corp (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials		947484713	manufacture(42961-009)

Establishment
Name	Address	ID/FEI	Business Operations
Camco Chemicals Company Inc		004238366	manufacture(42961-009)

Establishment
Name	Address	ID/FEI	Business Operations
Avmor		202107827	manufacture(42961-009)

Revised: 1/2019

Document Id: 4059f87b-b7fc-4367-8960-d82ce94ffce9

34390-5

Set id: 35b1e869-a033-449d-a378-5bed6050e308

Version: 2

Effective Time: 20190118