FDA.reportPublic FDA data

Bactakleen Ultra Mist (60ml)

Manufacturer
Excelsia Technologies Sdn Bhd | MBH Cosmeceutical Sdh Bhd
Effective date
2020-03-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:04:09

Label at a glance#

ProductBactakleen Ultra Mist (60ml)
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For sanitizing to decrease bacteria

Dosage and administration

Spray adequate amount to desired area.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride (0.1%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

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

For 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, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Spray adequate amount to desired area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled water, Vegetable Oil, Pine Oil, Salvia Officinalis (Sage) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Bactakleen Ultra Mist (60ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bactakleen ultra mist 60mlbactakleen ultra mist 60ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73215-108-012023-01-30C16284748780-1f386c649-aafe-0266-e053-dadaa90a7c1aBactakleen Ultra Mist (60ml)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73215-108-01Bactakleen Ultra Mist (60ml)60 mL in 1 BOTTLE, SPRAYLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73215-108BACTAKLEEN ULTRA MIST (60ML) (BENZALKONIUM CHLORIDE) LIQUID [EXCELSIA TECHNOLOGIES SDN BHD]3Legacy NDC, 1 package rows20200327_a163a117-ae3b-0433-e053-2995a90a23d0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73215-10873215-108-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SAGE OILU27K0H1H2OIACT
TEA TREE OILVIF565UC2GIACT
WHITE PINE OILHA5CX6676UIACT

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
a1639ff6-18a4-ef5b-e053-2995a90ab3a0a163a117-ae3b-0433-e053-2995a90a23d02020-03-21WarningsExact identifier
spl id: a1639ff6-18a4-ef5b-e053-2995a90ab3a0
spl set id: a163a117-ae3b-0433-e053-2995a90a23d0

Reported adverse events (FAERS/openFDA)#

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