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 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:

Behentrimonium chloride, Dihydroxyethyl cocamine oxide, Dihydroxypropyl PEG-5 linoleammonium chloride, Fragrance, Glycereth-2 cocoate, Water

Sanis

Foaming

Hand

Sanitizer

1000 ML 33.8 FL OZ

container label

FOAMING HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42961-003-01400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:42961-003-02800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:42961-003-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/200803/16/2016
Labeler - Cintas Corp. (056481716)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials947484713manufacture(42961-003)
Establishment
NameAddressID/FEIBusiness Operations
Camco Chemicals Company Inc004238366manufacture(42961-003)

Revised: 3/2016
Document Id: c6204e38-beef-46f7-bd67-051723ba4a37
Set id: 51b1554b-99cc-47f0-81f2-42b62fafef6b
Version: 2
Effective Time: 20160316
 
Cintas Corp.