FDA.reportPublic FDA data

Antiseptic Hand Sanitizer

Manufacturer
Hubei Fanjian Medical Product Co.,Ltd
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:59:11

Label at a glance#

ProductAntiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For handwashing to decrease bacteria on the skin Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

`Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame For external use only.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • imitation and redness develop
  • condition persists for more than 72 hours

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at 15°to 25°C (59°to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02Box1Box1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN4
247835ethanol 0.62 ML/ML Topical SolutionSCD4
247835ethanol 62 % Topical SolutionSY4
247835ethyl alcohol 62 % Topical SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83165-000-00Antiseptic Hand Sanitizer1.03 mL in 1 BOTTLELIQUID1.034

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83165-00083165-000-00

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALCOHOL3K9958V90MACTIB

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
Antiseptic Hand SanitizerALCOHOLHubei Fanjian Medical Product Co.,Ltd9b4014a3-6296-4628-9cc6-b8d4ef4a25f32026-05-28WarningsExact identifier
ndc (package): 83165-000-00
ndc (product): 83165-000
ndc11 (package): 83165000000
spl id: 52e1fab7-3ecd-821d-e063-6394a90a454a
spl set id: 9b4014a3-6296-4628-9cc6-b8d4ef4a25f3

Reported adverse events (FAERS/openFDA)#

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