HAND SANITIZER

Manufacturer
Biominerales Pharma
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:28

Label at a glance#

ProductHAND SANITIZER
Active ingredientIsopropyl alcohol
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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (70% v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Carbomer, Triethanolamine, Hydrogen Peroxide, Fragrance.

Use (s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentiallycan 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. Do not use in children less than 2 months of age or on open skin wounds. When using this product keep our of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. 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.

SPL UNCLASSIFIED SECTION

Distributed by:
Biominerales Pharma, LLC
Boca Raton, Florida 33442

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOMINERALES
PHARMA

Kills more than 99.99 % of germs

HAND SANITIZER

4 oz. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77110-400-052022-01-28C16284748780-1d6a99b39-ab51-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77110-400-05HAND SANITIZER118 mL in 1 BOTTLEGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77110-400HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [BIOMINERALES PHARMA]1Legacy NDC, 1 package rows20200715_b80e1605-1e08-4b81-889c-48e43d3d2848.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77110-40077110-400-05

Ingredients#

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

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

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
45102b6e-28e9-468e-b762-13d2e990f782b80e1605-1e08-4b81-889c-48e43d3d28482020-07-09WarningsExact identifier
spl id: 45102b6e-28e9-468e-b762-13d2e990f782
spl set id: b80e1605-1e08-4b81-889c-48e43d3d2848

Reported adverse events (FAERS/openFDA)#

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