FDA.reportPublic FDA data

HAND SANITIZER GEL

Manufacturer
Venus Oilfield Solutions Llc
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:43

Label at a glance#

ProductVENUS SOLUTIONS HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

On Children less than 2 months of age

On open skin wounds

When using the product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation 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.

Directions

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 Information

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, deionized water, Carbomer Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured by Shotwell Hydrogenics

Distributed by Venus Solutions,

LLC Midland, TX 79707

IttyBittySpider.com

Made in the USA

EXP 5/22

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77963-002-012022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-022022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-042022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-082022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-162022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-282022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL
77963-002-642022-01-28C16284748780-1d6a99b39-8dcb-a426-e053-dadaa90af4c2HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77963-002-01VENUS SOLUTIONS HAND SANITIZER29 mL in 1 BOTTLEGEL291
77963-002-02VENUS SOLUTIONS HAND SANITIZER59 mL in 1 BOTTLEGEL591
77963-002-04VENUS SOLUTIONS HAND SANITIZER118 mL in 1 BOTTLEGEL1181
77963-002-08VENUS SOLUTIONS HAND SANITIZER236 mL in 1 BOTTLEGEL2361
77963-002-16VENUS SOLUTIONS HAND SANITIZER473 mL in 1 BOTTLEGEL4731
77963-002-28VENUS SOLUTIONS HAND SANITIZER3785 mL in 1 BOTTLEGEL37851
77963-002-64VENUS SOLUTIONS HAND SANITIZER1892 mL in 1 BOTTLEGEL18921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77963-002VENUS SOLUTIONS HAND SANITIZER (ALCOHOL) GEL [VENUS OILFIELD SOLUTIONS LLC]1Legacy NDC, 7 package rows20200603_96cdbcaa-e898-46df-896e-76dd199a29ef.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
77963-00277963-002-01, 77963-002-02, 77963-002-04, 77963-002-08, 77963-002-16, 77963-002-64, 77963-002-28

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT

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
a2835db0-84dd-40ef-a5fa-7390304d87f396cdbcaa-e898-46df-896e-76dd199a29ef2020-05-22WarningsExact identifier
spl id: a2835db0-84dd-40ef-a5fa-7390304d87f3
spl set id: 96cdbcaa-e898-46df-896e-76dd199a29ef

Reported adverse events (FAERS/openFDA)#

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