FDA.reportPublic FDA data

MEDICAL GRADE HAND SANITIZER

Manufacturer
Biominerales Pharma
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:07

Label at a glance#

ProductMEDICAL GRADE HAND SANITIZER
Active ingredientALCOHOL
Label structure8 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol (70% v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate, Purified Water, Fragrance.

Use (s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep our 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 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.

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADVANCED PROTECTION
KILLS VIRUSES AND GERMS

SCIENTIFIC
SOLUTIONS

MEDICAL GRADE GEL HAND SANITIZER

70% ALCOHOL

(236ml/8oz)

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

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
77110-500-012022-01-28C16284748780-1d6a99b39-f899-a426-e053-dadaa90af4c2MEDICAL GRADE HAND SANITIZER
77110-500-022022-01-28C16284748780-1d6a99b39-f899-a426-e053-dadaa90af4c2MEDICAL GRADE HAND SANITIZER
77110-500-032022-01-28C16284748780-1d6a99b39-f899-a426-e053-dadaa90af4c2MEDICAL GRADE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77110-500-01MEDICAL GRADE HAND SANITIZER236 mL in 1 BOTTLEGEL2361
77110-500-02MEDICAL GRADE HAND SANITIZER473 mL in 1 BOTTLEGEL4731
77110-500-03MEDICAL GRADE HAND SANITIZER3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77110-500MEDICAL GRADE HAND SANITIZER (ALCOHOL) GEL [BIOMINERALES PHARMA]1Legacy NDC, 3 package rows20200722_5f5c14ff-41c4-44d9-b0ce-80acf9faa208.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
77110-50077110-500-01, 77110-500-02, 77110-500-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
72b1bb45-de73-44ff-bfd4-4766b83f9b705f5c14ff-41c4-44d9-b0ce-80acf9faa2082020-07-20WarningsExact identifier
spl id: 72b1bb45-de73-44ff-bfd4-4766b83f9b70
spl set id: 5f5c14ff-41c4-44d9-b0ce-80acf9faa208

Reported adverse events (FAERS/openFDA)#

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