PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER- benzalkonium chloride spray

Pristall SaniShield Alcohol Free Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Pristall SaniShield Alcohol Free Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sani Home Products International LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient                                                      Purpose

Benzalkonium Chloride 0.13 percent                      Antiseptic  

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use in eyes.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS AND PRECAUTIONS

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

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive Ingredients

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

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRISTALL SANISHIELD ALCOHOL FREE ANTISEPTIC HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50757-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50757-250-08	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	03/23/2010

Labeler - Sani Home Products International LLC (961615478)

Registrant - Sani Home Products International LLC (961615478)

Establishment
Name	Address	ID/FEI	Business Operations
Sani Home Products International LLC		961615478	manufacture