SANI-HANDS INSTANT HAND SANITIZING WIPES- alcohol cloth

Sani-Hands by

Drug Labeling and Warnings

Sani-Hands by is a Otc medication manufactured, distributed, or labeled by Professional Disposables International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

• For hand washing to decrease bacteria on the skin.
• Recommended for repeated use.
• Dries in seconds.

Warnings

• Flammable, keep away from fire or flame.
• For external use only.
• Do not use in or contact the eyes.
• Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a physician.
• If swallowed, get medical help or contact a Poison Control Center right away.

• Keep this out of reach of children unless under adult supervision.

Directions

• Tear open pouch
• Open and unfold wipe.
  
• Thoroughly wipe hands, fingers and wrists. Be sure to utilize the entire wipe.
• For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe.
• Discard after single use.

Other information

Lot No. and Expiration Date can be found on pouch, on packet or on top of carton.

Dosage

For dirty hand, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Discard after single use.

Inactive ingredients

Water, Propylene Glycol, Glycerin, Carbomer, Aminometyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

SPL UNCLASSIFIED SECTION

*Wipes composed of 50% Tencel,
50% Viscose, both made from renewable resources.
Tencel(R) is a registered trademark of Lenzing AG.

Manufactured for:
Nice-Pak Products, Inc.
Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
Made in USA

Principal Display Panel

Sani
Professional Brand

SANI-HANDS(R)
Instant Hand Sanitizing Wipes

#1 in Hospitals and Doctors' Offices

Clinically Proven More Effective than Gels

Kills 99.99% of Germs

Pouch Label

Individual packet

Box of 24 packets

Active ingredient

Alcohol 65.9% by volume

Purpose

Antiseptic

INGREDIENTS AND APPEARANCE

SANI-HANDS  INSTANT HAND SANITIZING WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10819-5811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.659 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10819-5811-8	8 in 1 POUCH
2	NDC: 10819-5811-9	24 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/08/2012

Labeler - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(10819-5811)