SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL- benzalkonium chloride cloth 
KPD, Limited Liability Company

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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Smile Antibacterial Wet Wipes D-panthenol

Drug Facts

Active Ingredient

Benzalkonium Chloride 0,1%

Purpose

Antibacterial

Uses

kill germs and remove dirt

Warnings

For external use only

Don't use 

if you are alleric to any of the any of ingredients

When using this product

do not get into eyes. If contact occurs, wash thoroughly with water

Stop use and ask doctor

if irritation or rash develops and continuous for more than 72 hours

Keep out of reach of children

Directions

Inactive ingredients:

aqua, glycerin, propylene glycol, tocopheyl acetate, sodium ascorbyl phosphate, retinyl palmitate, panthenol, PEG-40 hydrogenated castro oil, cocamidopropyl betaine, PPG-2-methyl ether, ethylparaben, 2-bromo-2-nitropropane-1,3-doil, centrimonium bromide, citric acid, parfum, limonene, hexyl cinnamal

Package Labeling:60 pcs

Label3

Package Labeling:15 pcs

Label4

SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81119-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PANTHENOL (UNII: WV9CM0O67Z)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ETHYLPARABEN (UNII: 14255EXE39)  
BRONOPOL (UNII: 6PU1E16C9W)  
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81119-002-6060 in 1 PACKAGE01/01/2021
13.736 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:81119-002-1515 in 1 PACKAGE01/01/2021
22.28 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2021
Labeler - KPD, Limited Liability Company (681241494)

Revised: 12/2020
Document Id: b60e3e37-96c6-9dac-e053-2a95a90a2d01
Set id: b60e3e37-96c5-9dac-e053-2a95a90a2d01
Version: 1
Effective Time: 20201209
 
KPD, Limited Liability Company