FDA.reportPublic FDA data

BACTAKLEEN KLEEN WIPES

Manufacturer
Excelsia Technologies Sdn Bhd | MBH Cosmeceutical Sdh Bhd
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:00

Label at a glance#

ProductBACTAKLEEN KLEEN WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Fro sanitizing to decrease bacteria

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride (0.08%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

INDICATIONS & USAGE SECTION

Fro sanitizing to decrease bacteria

Warnings

WARNINGS SECTION

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken skin

Stop use and ask a doctor if irritation or rash occurs. These may be sign of a serious condition.

DOSAGE & ADMINISTRATION SECTION

Open the package, remove and wipe hands as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water. Polyaminopropyl Biguanide, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

BACTAKLEEN KLEEN WIPES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kleenwipeskleenwipes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73215-110-012023-01-30C16284748780-1f386c64a-4921-0266-e053-dadaa90a7c1aBACTAKLEEN KLEEN WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73215-110-01BACTAKLEEN KLEEN WIPES100 in 1 POUCHLIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73215-110BACTAKLEEN KLEEN WIPES (BENZALKONIUM CHLORIDE) LIQUID [EXCELSIA TECHNOLOGIES SDN BHD]1Legacy NDC, 1 package rows20200729_ab872efa-05ec-191e-e053-2a95a90a46b2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73215-11073215-110-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT

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
ab872147-369a-0d09-e053-2a95a90a9403ab872efa-05ec-191e-e053-2a95a90a46b22020-07-28WarningsExact identifier
spl id: ab872147-369a-0d09-e053-2a95a90a9403
spl set id: ab872efa-05ec-191e-e053-2a95a90a46b2

Reported adverse events (FAERS/openFDA)#

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