FDA.reportPublic FDA data

Ethyl Alcohol Antiseptic Hand Sanitizer Gel

Manufacturer
Taizhou Duorui Biotechnology Co., Ltd.
Effective date
2021-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:58

Label at a glance#

ProductVIVITAR Ethyl Alcohol Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store below 110ºF (43ºC)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame
For external use only

Do not use

• in children less than 12 months of age • on open skin wounds

When using this product •  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other information 

STORAGE AND HANDLING SECTION

store below 110ºF (43ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe extract, alpha tocopherol, carbomer, fragrance (parfum), glycerin, triethanolamine, water

Questions? +1-800-592-9541

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number.
We are available 24x7

SPL UNCLASSIFIED SECTION

Distributed by

Sakar International
195 Carter Drive,
Edison, NJ 08817
www.vivitar.com
Made in China

VIVITAR®

© 2021

Keep All Relevant Information for Future Reference.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80800-004-012022-07-29C16284748780-1e4f33bdf-afb1-d8a0-e053-dadaa90a6e4eEthyl Alcohol Antiseptic Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80800-004-01VIVITAR Ethyl Alcohol Antiseptic Hand Sanitizer30 mL in 1 BOTTLEGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80800-004VIVITAR ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [TAIZHOU DUORUI BIOTECHNOLOGY CO., LTD.]2Legacy NDC, 1 package rows20210427_82c1d871-61b0-4ab9-b67b-8db506ef7271.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80800-00480800-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOEV5VD430YW9IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
cfcd1a29-8f6c-46f2-81ce-ba3c6d31ca5782c1d871-61b0-4ab9-b67b-8db506ef72712021-04-26WarningsExact identifier
spl id: cfcd1a29-8f6c-46f2-81ce-ba3c6d31ca57
spl set id: 82c1d871-61b0-4ab9-b67b-8db506ef7271

Reported adverse events (FAERS/openFDA)#

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