NICE N CLEAN ANTIBACTERIAL HAND WIPES- antibacterial hand wipes swab 
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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10819-7013 NNC Antibac

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic

Use

To decrease bacteria on the skin

Warnings

  • For external use only.
  • Do not use in the eyes.
  • Flammable, keep away form fire or flame.

Keep out of reach of children

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

Discontinue use if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Directions

  • Peel back label slowly
  • Pull out wipe and reseal label
  • Unfold and use, discarding after single use.
  • Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

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

Principal Display Panel

Packette: packette

web 20 ct:

20ct

Box:

Box

web 30 ct

30 ct

Web 110ct

web 110ct

reseal 110ct

reseal

NICE N CLEAN ANTIBACTERIAL HAND WIPES 
antibacterial hand wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-7013
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
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10819-7013-12.46 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2015
2NDC:10819-7013-35 in 1 BOX03/01/2018
2NDC:10819-7013-210 in 1 TRAY
246.13 mL in 1 CELLO PACK; Type 0: Not a Combination Product
3NDC:10819-7013-483.03 mL in 1 CELLO PACK; Type 0: Not a Combination Product07/09/2018
4NDC:10819-7013-5320 mL in 1 CELLO PACK; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/201512/31/2022
Labeler - Professional Disposables International Inc (800777117)

Revised: 10/2021
Document Id: cea75ddb-b3d5-07dd-e053-2995a90ad25a
Set id: 2655e449-dedd-57d1-e054-00144ff88e88
Version: 7
Effective Time: 20211018
 
Professional Disposables International Inc