SANI PROFESSIONAL BRAND SANI-HANDS INSTANT HAND SANITIZING WIPES- alcohol 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.

----------

Sani Pro Sani-Hands 300ct NDC 10819-6002

Active ingredient

Alcohol 65.9% by volume

Purpose

Anitmicrobial

Uses

  • Hand sanitizer to decrease bacteria on the skin.
  • For repeated use.
  • Dries in seconds.

Warnings

  • Flammable, keep away form fire or flame.
  • For external use only
  • Do not use in or contact the eyes.
  • Discontinue use if irritation and 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 Cneter right away.

Directions

  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss.
  • Use entire wipe to thoroughly wipe hands, fingers, and wrists.
  • To sanitize, use multiple wipes.
  • Discard after single use.

Inactive ingredients

Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

Food Code Compliant

Nonfood Compounds

Program Listed E3

Registration #151433

Principal Display Panel 300ct

kills 99.99% of germs

Cleans more effectively than gel

FDA Food Code Compliant

300 wipes

pre-moistened

7.5 x 5.0 in (19 x 12.7 cm)

Effective against foodborne pathogens

Ideal for hand sanitizer when soap and water are not readily available

Front label: frontlabel

Back label: backlabel

SANI PROFESSIONAL BRAND SANI-HANDS  INSTANT HAND SANITIZING WIPES
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-6002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.659 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10819-6002-3993.96 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/200912/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/200812/31/2022
Labeler - Professional Disposables International Inc (800777117)
Registrant - Professional Disposables International Inc (800777117)
Establishment
NameAddressID/FEIBusiness Operations
Professional Disposables International Inc800777117manufacture(10819-6002)

Revised: 10/2021
Document Id: cf342e11-0ca4-3434-e053-2a95a90a0535
Set id: 7ab0f9b6-1f06-4005-9503-94bfde09b869
Version: 5
Effective Time: 20211025
 
Professional Disposables International Inc