SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL- benzalkonium chloride cloth

Smile Antibacterial Wet Wipes D-panthenol by

Drug Labeling and Warnings

Smile Antibacterial Wet Wipes D-panthenol 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, 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

Package Labeling:15 pcs

INGREDIENTS AND APPEARANCE

SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81119-002
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)
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81119-002-60	60 in 1 PACKAGE	01/01/2021
1		3.736 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 81119-002-15	15 in 1 PACKAGE	01/01/2021
2		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	01/01/2021

Labeler - KPD, Limited Liability Company (681241494)