SMILE ANTIBACTERIAL WET WIPES PLANTAIN EXTRACT- benzalkonium chloride cloth

Smile Antibacterial Wet Wipes Plantain Extract by

Drug Labeling and Warnings

Smile Antibacterial Wet Wipes Plantain Extract by is a Otc medication manufactured, distributed, or labeled by KPD, Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 3 years and over
• Children under 3 years ask a doctor before use
• Wipe with wipes and let dry

Inactive ingredients:

aqua, glycerin, propylene glycol, plangato major leaf extract, PEG-40 hydrogenated castro oil, cocamidopropyl betaine, PPG-2-methyl ether, ethylparaben, 2-bromo-2-nitropropane-1,3-doil, centrimonium bromide, citric acid, parfum, linalool, butylphenyl methylpropional

Package Labeling:

INGREDIENTS AND APPEARANCE

SMILE ANTIBACTERIAL WET WIPES PLANTAIN EXTRACT 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81119-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)
ETHYLPARABEN (UNII: 14255EXE39)
BRONOPOL (UNII: 6PU1E16C9W)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81119-001-15	15 in 1 PACKAGE	05/01/2020
1		2.28 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - KPD, Limited Liability Company (681241494)