FDA.reportPublic FDA data

InvisAssure Hydrating Hand Sanitizer

Manufacturer
Hangzhou Changing Time Biotechnology Co.,Ltd
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:38:55

Label at a glance#

ProductInvisAssure Hydrating Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Pump small amount of hand sanitizer into palm of harnd. Rub thoroughly over all surfaces of both hands. Rub hands briskly until dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride（0.13%）

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USES

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

WARNINGS

WARNINGS SECTION

For External use only.

When using this product avoid contact with eyes and nose.
In case of contact flush eyes witth water.

Stop use and consult a docttor if irritation or redness dlevelops.

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

OTC - DO NOT USE SECTION

/

WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product avoid contact with eyes and nose.
In case of contact flush eyes witth water.

OTC - STOP USE SECTION

Stop use and consult a docttor if irritation or redness dlevelops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Pump small amount of hand sanitizer into palm of harnd. Rub thoroughly over all surfaces of both hands. Rub hands briskly until dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (deionized watter), aloe vera, glycerin, 3-(trimethoxys.itiyl) PropyldimOvethyloctadecyl ammonium chloride

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75153-013-01 50.2mL 75153-013-01 50.2 ML75153-013-01 50.2 ML

75153-013-02 50.2mL

75153-013-02 50.2mL75153-013-02 50.2mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN4
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD4
1049254benzalkonium chloride 0.13 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75153-013-012022-07-29C16284748780-1e4f33bdf-b004-d8a0-e053-dadaa90a6e4e75153-013 InvisAssure Hydrating Hand Sanitizer
75153-013-022022-07-29C16284748780-1e4f33bdf-b004-d8a0-e053-dadaa90a6e4e75153-013 InvisAssure Hydrating Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75153-013-01InvisAssure Hydrating Hand Sanitizer50.2 mL in 1 BOTTLELIQUID50.24
75153-013-02InvisAssure Hydrating Hand Sanitizer50.2 mL in 1 BOTTLELIQUID50.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75153-013INVISASSURE HYDRATING HAND SANITIZER LIQUID [HANGZHOU CHANGING TIME BIOTECHNOLOGY CO.,LTD]4Legacy NDC, 2 package rows20210312_af1a6e10-6a0f-72bb-e053-2a95a90aa3b6.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
75153-01375153-013-01, 75153-013-02

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT

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
bd406660-6d69-7f22-e053-2995a90a39a2af1a6e10-6a0f-72bb-e053-2a95a90aa3b62021-03-11WarningsExact identifier
spl id: bd406660-6d69-7f22-e053-2995a90a39a2
spl set id: af1a6e10-6a0f-72bb-e053-2a95a90aa3b6

Reported adverse events (FAERS/openFDA)#

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