SANI-HANDS FOR KIDS ANTIBACTERIAL MOIST WIPES- benzalkonium chloride cloth 
Professional Disposables International, Inc.

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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SANI-HANDS FOR KIDS ANTIBACTERIAL MOIST WIPES

Use

For hand washing to decrease bacteria on the skin

Warnings

Keep out of reach of children.

Directions

Other information

Lot No. and Exp. date - on side

Dosage

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

Inactive ingredients

Water, SD Alcohol 40, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
Made in USA

Principal Display Panel - 10 Count

Sani-Hands for Kids
Antibacterial Moist Wipes

Kills 99.99% of Germs
Moisturizes with Aloe

15 wipes per Paks [5.0 in x 8.0 in (12.7 cm x 20.3 cm)] 10 Paks per Tray

Flow Wrap Label
Image of pak label
Reseal label
image of reseal
Tray Label
Image of tray label

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic handwash

SANI-HANDS FOR KIDS  ANTIBACTERIAL MOIST WIPES
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-7010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBIC ACID (UNII: X045WJ989B)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MICROCITRUS AUSTRALIS FRUIT (UNII: 9DNS80T428)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10819-7010-110 in 1 TRAY
138.3 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2013
Labeler - Professional Disposables International, Inc. (800777117)
Establishment
NameAddressID/FEIBusiness Operations
Professional Disposables International, Inc.800777117manufacture(10819-7010)

Revised: 12/2013
Document Id: 34f254d2-7b23-412a-bacc-69ebdea7fbb8
Set id: e72f98ab-a657-455d-83ed-ad2a6d01a249
Version: 1
Effective Time: 20131226
 
Professional Disposables International, Inc.