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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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

container label


ANTIBACTERIAL FOAMING HAND  
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.125 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYLAMINE OXIDE 
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE 
PEG-4 RAPESEEDAMIDE 
DIHYDROXYETHYL COCAMINE OXIDE 
DMDM HYDANTOIN 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 4 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:42961-001-01400 mL in 1 BOTTLE, PLASTICNone
2NDC:42961-001-02800 mL in 1 BOTTLE, PLASTICNone
3NDC:42961-001-05500 mL in 1 BAGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/22/2008

Labeler - Cintas Corp. (056481716)
Establishment
NameAddressID/FEIOperations
Natural Essentials947484713manufacture
Establishment
NameAddressID/FEIOperations
Camco Chemicals Company Inc004238366manufacture
Establishment
NameAddressID/FEIOperations
Avmor202107827manufacture

Revised: 10/2011 Cintas Corp.