FDA.reportPublic FDA data

Ecosol Hand sanitizer

Manufacturer
Ecosolutions, S. de R.L. de C.V.
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:53

Label at a glance#

ProductEcosol Hand sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% 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

water, ethyl alcohol, lauryl glucoside, n-alkyl-n-dimethyl ammonium chloride, grapefruit seed extract.

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 77993-005-01 PDP 1000 mlPDP 1000 ml

5000 mL NDC: 77993-005-02 PDP 5000 mlPDP 5000 ml

20000 mL NDC: 77993-005-03 PDP 20000 mlPDP 20000 ml

200000 mL NDC: 77993-005-04 PDP 200000 mlPDP 200000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77993-005-012022-01-28C16284748780-1d6a99b39-47f4-a426-e053-dadaa90af4c2Hand sanitizer
77993-005-022022-01-28C16284748780-1d6a99b39-47f4-a426-e053-dadaa90af4c2Hand sanitizer
77993-005-032022-01-28C16284748780-1d6a99b39-47f4-a426-e053-dadaa90af4c2Hand sanitizer
77993-005-042022-01-28C16284748780-1d6a99b39-47f4-a426-e053-dadaa90af4c2Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77993-005-01Ecosol Hand sanitizer1000 mL in 1 BOTTLE, SPRAYLIQUID10001
77993-005-02Ecosol Hand sanitizer5000 mL in 1 BOTTLE, SPRAYLIQUID50001
77993-005-03Ecosol Hand sanitizer20000 mL in 1 BOTTLELIQUID200001
77993-005-04Ecosol Hand sanitizer200000 mL in 1 CONTAINERLIQUID2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77993-005ECOSOL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ECOSOLUTIONS, S. DE R.L. DE C.V.]1Legacy NDC, 4 package rows20200922_afdc185e-76b1-b47e-e053-2995a90a2618.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77993-00577993-005-01, 77993-005-02, 77993-005-03, 77993-005-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
3-CHLORO-2-HYDROXYPROPYLCOCOALKYLDIMETHYLAMMONIUM CHLORIDE0V8LAK7MX8IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
WATER059QF0KO0RIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
METHYL ALCOHOLY4S76JWI15IACT

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
afdc185e-76b0-b47e-e053-2995a90a2618afdc185e-76b1-b47e-e053-2995a90a26182020-09-21WarningsExact identifier
spl id: afdc185e-76b0-b47e-e053-2995a90a2618
spl set id: afdc185e-76b1-b47e-e053-2995a90a2618

Reported adverse events (FAERS/openFDA)#

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