FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Mp Three, S.A. de C.V.
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:58

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Deionized water
  3. Carbomer 940
  4. Glycerin
  5. Triethanolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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 ingredients

INACTIVE INGREDIENT SECTION

Deionized water, carbomer 940, glycerin, triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ml NDC: 79528-001-01

Hands protect 1 L LabelHands protect 1 L Label3780 ml NDC: 79528-001-02

Hands protect 3.78 L LabelHands protect 3.78 L Label60 ml NDC: 79528-001-03

Hands protect 60 mL LabelHands protect 60 mL Label125 ml NDC: 79528-001-04

Hands protect 125 mL LabelHands protect 125 mL Label250 ml NDC: 79528-001-05

Hands protect 500 mL LabelHands protect 500 mL Label500000 ml NDC: 79528-001-06

Hands protect 500 L LabelHands protect 500 L Label100000 ml NDC: 79528-001-07

Hands protect 1000 L LabelHands protect 1000 L Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79528-001-012022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-022022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-032022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-042022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-052022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-062022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER
79528-001-072022-01-28C16284748780-1d6a99b39-dd67-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79528-001-01Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
79528-001-02Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37801
79528-001-03Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
79528-001-04Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1251
79528-001-05Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
79528-001-06Hand Sanitizer500000 mL in 1 CONTAINERGEL5000001
79528-001-07Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79528-001HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [MP THREE, S.A. DE C.V.]1Legacy NDC, 7 package rows20200711_aa193968-a2d7-426c-e053-2a95a90afa33.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
79528-00179528-001-01, 79528-001-02, 79528-001-03, 79528-001-04, 79528-001-05, 79528-001-06, 79528-001-07

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
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
aa191f20-a7cf-ef54-e053-2995a90ab66daa193968-a2d7-426c-e053-2a95a90afa332020-07-10WarningsExact identifier
spl id: aa191f20-a7cf-ef54-e053-2995a90ab66d
spl set id: aa193968-a2d7-426c-e053-2a95a90afa33

Reported adverse events (FAERS/openFDA)#

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