FDA.reportPublic FDA data

Antiseptic Hand Sanitizer Ethyl Alcohol

Manufacturer
M-star (Hubei) Health&Care Products Co., Ltd.
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:25

Label at a glance#

ProductAntiseptic Hand Sanitizer Ethyl Alcohol
Active ingredientALCOHOL
Label structure8 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 ingredient

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

  • irritation 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 room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

Question?

OTC - QUESTIONS SECTION

+1(855)924-2182

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9.jpgLabel9.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN1
247835ethanol 0.62 ML/ML Topical SolutionSCD1
247835ethanol 62 % Topical SolutionSY1
247835ethyl alcohol 62 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84219-005-00Antiseptic Hand Sanitizer Ethyl Alcohol0.9 g in 1 POUCHLIQUID0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-005ANTISEPTIC HAND SANITIZER ETHYL ALCOHOL (ALCOHOL) LIQUID [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 1 package rows20240515_01159887-0d27-4aef-8187-c0b8fed4b1bb.zip

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
84219-00584219-005-00

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 Sanitizer Ethyl AlcoholALCOHOLM-star (Hubei) Health&Care Products Co., Ltd.01159887-0d27-4aef-8187-c0b8fed4b1bb2024-04-01WarningsExact identifier
ndc (package): 84219-005-00
ndc (product): 84219-005
ndc11 (package): 84219000500
spl id: 15078c5d-2c1e-7e71-e063-6394a90ad193
spl set id: 01159887-0d27-4aef-8187-c0b8fed4b1bb

Reported adverse events (FAERS/openFDA)#

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