FDA.reportPublic FDA data

Apple scented hand sanitizer

Manufacturer
Foshan Astar Industry Co., Ltd
Effective date
2021-07-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:18

Label at a glance#

ProductApple scented hand sanitizer 01
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient purpose

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1% Antibacterial

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

For external use only-hands

keep out of eyes- avoid contact with broken skin

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

DOSAGE & ADMINISTRATION SECTION

Rub a dime sized drop into hands.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For children under 6 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER, GLYCERIN, COCETH-7, PPG-1-PEG-9 LAURYL GLYCOL ETHER, CARBOMER, SODIUM HYDROXIDE, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM).
MAY CONTAIN: RED 40, RED 33, BLUE 1, YELLOW 5.

Questions?

OTC - QUESTIONS SECTION

1-212-779-0544 weekdays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77901-013-0177901-013-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN2
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD2
1049228benzalkonium chloride 0.1 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77901-013-012022-07-29C16284748780-1e4f33bdf-9df1-d8a0-e053-dadaa90a6e4eMB0075SA，light orange, apple Foshan Astar

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77901-013-01Apple scented hand sanitizer0159 mL in 1 BOTTLE, PLASTICGEL592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77901-013APPLE SCENTED HAND SANITIZER 01 (BENZALKONIUM CHLORIDE) GEL [FOSHAN ASTAR INDUSTRY CO., LTD]2Legacy NDC, 1 package rows20210708_a95c2d97-a63a-23b5-e053-2995a90a3986.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77901-01377901-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCETH-758Y261JLH5IACT
PPG-1-PEG-9 LAURYL GLYCOL ETHER5R8J43K25LIACT
WATER O-187QV8F8BYNJIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 934Z135WT9208IACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
APPLEB423VGH5S9IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FD&C RED NO. 40WZB9127XOAIACT

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
c6949142-c173-977e-e053-2995a90adb74a95c2d97-a63a-23b5-e053-2995a90a39862021-07-07WarningsExact identifier
spl id: c6949142-c173-977e-e053-2995a90adb74
spl set id: a95c2d97-a63a-23b5-e053-2995a90a3986

Reported adverse events (FAERS/openFDA)#

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