PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER - benzalkonium chloride spray 
Sani Home Products International LLC

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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Pristall SaniShield Alcohol Free Antiseptic Hand Sanitizer Spray

Drug Facts

Active Ingredient                                                      Purpose

Benzalkonium Chloride 0.13 percent                      Antiseptic  

Uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only.

Do not use in eyes.

Discontinue if irritation or redness develop. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact  a Poison Control Center right away

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Inactive Ingredients

Cocoamidopropyl Betaine, Edetate Sodium USP Dihydrate, Fragrance, Hydroxypropyl Cellulose, Propylene Glycol, Water

Lot No.       Expiration Date      Made in USA   Manufactured by: Sani Home Products International, LLC 15 Frowein Road Buiding E Suite 2 Center Moriches, NY 11934

Pristall          SaniShield      It's not clean until it's SaniClean      Alcohol Free Antiseptic Hand Sanitizer Spray   Kills Germs Not Your Skin  8.45 fl oz (250 ml)

PristallSaniShieldHandSanitizerSpray250ml

PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50757-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50757-250-08250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/23/2010
Labeler - Sani Home Products International LLC (961615478)
Registrant - Sani Home Products International LLC (961615478)
Establishment
NameAddressID/FEIBusiness Operations
Sani Home Products International LLC961615478manufacture

Revised: 3/2010
Document Id: f948039e-0c16-46d4-82a3-5ff69ab9efaa
Set id: 6ce271e2-846b-408a-b97e-d251d81890e3
Version: 3
Effective Time: 20100323
 
Sani Home Products International LLC