Sani-Hands Ii Instant Hand Sanitizing Wipes (Alcohol) Cloth [Profesional Disposables International, Inc.] -

SANI-HANDS II INSTANT HAND SANITIZING WIPES (ALCOHOL) CLOTH [PROFESIONAL DISPOSABLES INTERNATIONAL, INC.]
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NDC	10819-5802-3
Set ID	55e37581-4d11-493f-a772-27c24160ecac
Category	HUMAN OTC DRUG LABEL
Packager	Profesional Disposables International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333A

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Uses
- For hand sanitizing to decrease bacteria on the skin.
- Apply topically to the skin to help prevent cross-contamination.
- 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 immediately.
- Keep this out of reach of children unless under adult supervision.
Directions
- To start feed: Remove cover and discard seal from container. From center of wipe roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90o angle. Keep center cap closed to prevent moisture loss.
- Thoroughly wipe hands, fingers and wrists. Be sure to use 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 canister.

Dosage

For dirty hands, 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

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
www.saniprofessional.com
Principal Display Panel - 220 Count Canister
Sani Hands(R) II

Instant Hand Sanitizing Wipes
- Kills 99.99% of Germs (a 4 log10 reduction)
- Antimicrobial
- Hand sanitizer to decrease bacteria on skin
- Safe, gentle and effective
- Contains an emollient and vitamin E
220 Wipes
6 x 7.5 in (15.2 x 19.0 cm)

Front Canister Label

Back Canister Label
Active ingredient

Alcohol 65.9% by volume
Purpose

Antiseptic

INGREDIENTS AND APPEARANCE

SANI-HANDS II INSTANT HAND SANITIZING WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10819-5802
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.659 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10819-5802-3	814 mL in 1 CANISTER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2007

Labeler - Profesional Disposables International, Inc. (800777117)

Name	Address	ID/FEI	Business Operations
Establishment
Profesional Disposables International, Inc.		800777117	manufacture

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Medic

SANI-HANDS II INSTANT HAND SANITIZING WIPES (ALCOHOL) CLOTH [PROFESIONAL DISPOSABLES INTERNATIONAL, INC.]

Dosage

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