FDA.reportPublic FDA data

Substance surface disinfectant

Manufacturer
Hangzhou Changing Time Biotechnology Co.,Ltd
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:37

Label at a glance#

ProductSubstance surface disinfectant
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

Used for disinfection in the space, general substance surface(wall,floor,stool, bathtub,table), mobile phone,computer, fabric,furniture,surface, skin, etc

Dosage and administration

Use soon after opening.Use by pressing the nozzle placing outwards Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15℃-30℃(59°F-86°F) Avoid freezing and excessive heat above 40C(104F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.2% v/v.

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

USES

INDICATIONS & USAGE SECTION

Used for disinfection in the space, general substance surface(wall,floor,stool, bathtub,table), mobile phone,computer, fabric,furniture,surface, skin, etc

WARNINGS

WARNINGS SECTION

For external use only.

WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.Keep out of reach of children.If swallowed,

get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed,get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use soon after opening.Use by pressing the nozzle placing outwards Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store between 15℃-30℃(59°F-86°F)

Avoid freezing and excessive heat above 40C(104F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua, Polihexanide Hydrochloride.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 ml label100 ml label500 ml label500 ml label208198 ml label208198 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75153-012-012022-01-28C16284748780-1d6a99b39-4152-a426-e053-dadaa90af4c2Substance surface disinfectant
75153-012-022022-01-28C16284748780-1d6a99b39-4152-a426-e053-dadaa90af4c2Substance surface disinfectant
75153-012-032022-01-28C16284748780-1d6a99b39-4152-a426-e053-dadaa90af4c2Substance surface disinfectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75153-012-01Substance surface disinfectant100 mL in 1 BOTTLELIQUID1002
75153-012-02Substance surface disinfectant500 mL in 1 BOTTLELIQUID5002
75153-012-03Substance surface disinfectant208198 mL in 1 BOTTLELIQUID2081982

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75153-012SUBSTANCE SURFACE DISINFECTANT LIQUID [HANGZHOU CHANGING TIME BIOTECHNOLOGY CO.,LTD]2Legacy NDC, 3 package rows20200701_a42a1616-87bf-251b-e053-2a95a90a51f1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75153-01275153-012-01, 75153-012-02, 75153-012-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
POLIHEXANIDE HYDROCHLORIDE4XI6112496IACT

Source Document#

Source XML · Source PDF

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
a959054b-7cd0-39d9-e053-2995a90a2011a42a1616-87bf-251b-e053-2a95a90a51f12020-06-30WarningsExact identifier
spl id: a959054b-7cd0-39d9-e053-2995a90a2011
spl set id: a42a1616-87bf-251b-e053-2a95a90a51f1

Reported adverse events (FAERS/openFDA)#

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