FDA.reportPublic FDA data

Smile Antibacterial Wet Wipes Plantain Extract

Manufacturer
KPD, Limited Liability Company
Effective date
2020-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:54

Label at a glance#

ProductSmile Antibacterial Wet Wipes Plantain Extract
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

kill germs and remove dirt

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0,1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

kill germs and remove dirt

Warnings

WARNINGS SECTION

For external use only

Don't use 

OTC - DO NOT USE SECTION

if you are alleric to any of the any of ingredients

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask doctor

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81119-001-152022-01-28C16284748780-1d6a99b39-669f-a426-e053-dadaa90af4c2Smile Antibacterial Wet Wipes Plantain Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81119-001-15Smile Antibacterial Wet Wipes Plantain Extract15 in 1 PACKAGECLOTH151
81119-001-15Smile Antibacterial Wet Wipes Plantain Extract2.28 mL in 1 PATCHCLOTH2.281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81119-001SMILE ANTIBACTERIAL WET WIPES PLANTAIN EXTRACT (BENZALKONIUM CHLORIDE) CLOTH [KPD, LIMITED LIABILITY COMPANY]1Legacy NDC, 2 package rows20201210_b60e1bc1-0cd9-9179-e053-2995a90a2748.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81119-00181119-001-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PPG-2 METHYL ETHERRQ1X8FMQ9NIACT
ETHYLPARABEN14255EXE39IACT
BRONOPOL6PU1E16C9WIACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CITRALT7EU0O9VPPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b60e1223-b9df-97d5-e053-2995a90a84e8b60e1bc1-0cd9-9179-e053-2995a90a27482020-12-09WarningsExact identifier
spl id: b60e1223-b9df-97d5-e053-2995a90a84e8
spl set id: b60e1bc1-0cd9-9179-e053-2995a90a2748

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.