FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Biominerales Pharma
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:22:45

Label at a glance#

ProductHand 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.

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 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.

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. 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 MPP Dist. LLC.

PRINCIPAL DISPLAY PANEL - 2 FL Oz. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol Antiseptic 70%
Topical Solution

MPP
INSTANT
HAND
SANITIZER

Hand Sanitizer
Non-Sterile Solution
2 FL Oz.

Kills 99.9% of Germs

PRINCIPAL DISPLAY PANEL - 2 FL Oz. Bottle Label
PRINCIPAL DISPLAY PANEL - 2 FL Oz. Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77110-210-012022-01-28C16284748780-1d6a99b39-dee0-a426-e053-dadaa90af4c2HAND SANITIZER
77110-210-022022-01-28C16284748780-1d6a99b39-dee0-a426-e053-dadaa90af4c2HAND SANITIZER
77110-210-032022-01-28C16284748780-1d6a99b39-dee0-a426-e053-dadaa90af4c2HAND SANITIZER
77110-210-042022-01-28C16284748780-1d6a99b39-dee0-a426-e053-dadaa90af4c2HAND SANITIZER
77110-210-062022-01-28C16284748780-1d6a99b39-dee0-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77110-210-01Hand Sanitizer3785.41 mL in 1 BOTTLESOLUTION3785.413
77110-210-02Hand Sanitizer944 mL in 1 BOTTLESOLUTION9443
77110-210-03Hand Sanitizer473 mL in 1 BOTTLESOLUTION4733
77110-210-04Hand Sanitizer236 mL in 1 BOTTLESOLUTION2363
77110-210-06Hand Sanitizer59 mL in 1 BOTTLESOLUTION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77110-210HAND SANITIZER (ALCOHOL) SOLUTION [BIOMINERALES PHARMA]3Legacy NDC, 5 package rows20200728_05fc524e-7ee9-4096-a5a7-57f426a992ca.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
77110-21077110-210-06, 77110-210-01, 77110-210-02, 77110-210-03, 77110-210-04

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
e0fcc752-704d-4438-9391-adbbebe1fb4305fc524e-7ee9-4096-a5a7-57f426a992ca2020-07-27WarningsExact identifier
spl id: e0fcc752-704d-4438-9391-adbbebe1fb43
spl set id: 05fc524e-7ee9-4096-a5a7-57f426a992ca

Reported adverse events (FAERS/openFDA)#

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