FDA.reportPublic FDA data

ADVANCED HAND SANITIZER

Manufacturer
Biominerales Pharma, LLC
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:55

Label at a glance#

ProductADVANCED 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 or misuse.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

Active Ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin when water and soap are not available.

WARNINGS

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • Children under 6 years of a age should be supervise when using this product
  • On open skin wounds

OTC - WHEN USING SECTION

When using this product 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 for more than 72 hours, consult a doctor.

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 or misuse.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen, peroxide, purified water USP

PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOMINERALES
PHARMA

ADVANCED
HAND SANITIZER

Kills more than 99.99% of germs

Prevention:
Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
Keep container tightly closed.

Response:
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing. If eye
irritation persists: Get medical advice/ attention. In case of fire: Use
dry sand, dry chemical or alcohol-resistant foam for extinction.

Storage:
Store in a well-ventilated place. Keep cool.

Disposal:
Dispose of contents/ container to an approved waste disposal plant.

Active ingredients
Ethyl Alcohol 80%
Glycerin 1.45%
Hydrogen Peroxide .125%
Sterilized water 18.425%

Net Contents 3785 ML

Made in the USA

PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77110-100-012022-01-28C16284748780-1d6a99b39-8ae5-a426-e053-dadaa90af4c2ADVANCED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77110-100-01ADVANCED HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77110-100ADVANCED HAND SANITIZER (ALCOHOL) GEL [BIOMINERALES PHARMA, LLC]1Legacy NDC, 1 package rows20200513_619d802c-ec12-4f59-b34c-c53a7c5c2a6d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77110-10077110-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
175f8335-e49f-4031-bb57-0fcd244bf70b619d802c-ec12-4f59-b34c-c53a7c5c2a6d2020-05-06WarningsExact identifier
spl id: 175f8335-e49f-4031-bb57-0fcd244bf70b
spl set id: 619d802c-ec12-4f59-b34c-c53a7c5c2a6d

Reported adverse events (FAERS/openFDA)#

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