FDA.reportPublic FDA data

LS31

Manufacturer
Vincit Zee Company
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:23:14

Label at a glance#

ProductLS31
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

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

Label contents#

Full prescribing information#

active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol

purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat and open flame.

OTC - DO NOT USE SECTION

Do not use on children less than 2 months of age or on open skin wounds.

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

other safety information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

water, acrylates copolymer, glycerin, aminomethyl propanol, hydroxypropyl methylcellulose, fragrance

LS31 Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

263.59 ml: NDC Code 77093-221-01 263.59 ml label263.59 ml label

473.18 ml: NDC Code 77093-221-02 473.18 ml label473.18 ml label

3785ml : NDC Code 77093-221-03 3785 ml label3785 ml label

208000ml: NDC Code 77093-221-05 208000 ml drum208000 ml drum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN6
582753ethanol 0.7 ML/ML Topical SolutionSCD6
582753ethanol 70 % Topical SolutionSY6
582753ethyl alcohol 70 % Topical SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77093-221-012024-01-30C16284748780-11030e365-16fc-111a-e063-dadaa90a10e2LS31 Cummings Rd.
77093-221-022024-01-30C16284748780-11030e365-16fc-111a-e063-dadaa90a10e2LS31 Cummings Rd.
77093-221-032024-01-30C16284748780-11030e365-16fc-111a-e063-dadaa90a10e2LS31 Cummings Rd.
77093-221-052024-01-30C16284748780-11030e365-16fc-111a-e063-dadaa90a10e2LS31 Cummings Rd.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77093-221-01LS31236.59 mL in 1 BOTTLE, PLASTICLIQUID236.596
77093-221-02LS31473.18 mL in 1 BOTTLE, PLASTICLIQUID473.186
77093-221-03LS313785 mL in 1 BOTTLE, PLASTICLIQUID37856
77093-221-05LS31208000 mL in 1 DRUMLIQUID2080006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77093-221LS31 (ETHYL ALCOHOL HAND SANITIZER) LIQUID [VINCIT ZEE COMPANY]6Legacy NDC, 4 package rows20200731_a618fda6-824d-ba54-e053-2995a90a85a7.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77093-22177093-221-01, 77093-221-02, 77093-221-03, 77093-221-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSES3NXW29V3WOIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT

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
abadb633-551d-03c1-e053-2a95a90aa5eda618fda6-824d-ba54-e053-2995a90a85a72020-07-30WarningsExact identifier
spl id: abadb633-551d-03c1-e053-2a95a90aa5ed
spl set id: a618fda6-824d-ba54-e053-2995a90a85a7

Reported adverse events (FAERS/openFDA)#

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