FDA.reportPublic FDA data

EnviroClean Hand Sanitizer Gel

Manufacturer
EnviroServe Chemicals, Inc
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:17:02

Label at a glance#

ProductEnviroClean Hand Sanitizer Gel
Active ingredientISOPROPYL ALCOHOL
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

Isopropyl Alcohol 65% 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

carbomer homopolymer, aminomethylpropanol, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 mL NDC: 76563-3010-1

pintpint

3780 mL NDC: 76563-3010-2

gallongallon

18.9 L NDC: 76563-3010-3

pailpail

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76563-3010-12022-01-28C16284748780-1d6a99b39-c27c-a426-e053-dadaa90af4c2a3fdb3d6-3804-c785-e053-2a95a90a3910
76563-3010-22022-01-28C16284748780-1d6a99b39-c27c-a426-e053-dadaa90af4c2a3fdb3d6-3804-c785-e053-2a95a90a3910
76563-3010-32022-01-28C16284748780-1d6a99b39-c27c-a426-e053-dadaa90af4c2a3fdb3d6-3804-c785-e053-2a95a90a3910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76563-3010-1EnviroClean Hand Sanitizer Gel473 mL in 1 BOTTLE, PUMPGEL4733
76563-3010-2EnviroClean Hand Sanitizer Gel3780 mL in 1 BOTTLE, PUMPGEL37803
76563-3010-3EnviroClean Hand Sanitizer Gel1893 mL in 1 PAILGEL18933

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76563-3010ENVIROCLEAN HAND SANITIZER GEL (ISOPROPYL ALCOHOL GEL) GEL [ENVIROSERVE CHEMICALS, INC]3Legacy NDC, 3 package rows20200611_a3fdb3d6-3804-c785-e053-2a95a90a3910.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
76563-301076563-3010-1, 76563-3010-2, 76563-3010-3

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
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a7bcff8c-3149-7abc-e053-2995a90aacf8a3fdb3d6-3804-c785-e053-2a95a90a39102020-05-18WarningsExact identifier
spl id: a7bcff8c-3149-7abc-e053-2995a90aacf8
spl set id: a3fdb3d6-3804-c785-e053-2a95a90a3910

Reported adverse events (FAERS/openFDA)#

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