FDA.reportPublic FDA data

Prevent+ Gel Sanitizer

Manufacturer
Eco-Med Pharmaceuticals, Inc.
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:17

Label at a glance#

ProductPrevent Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

For personal hand hygiene to help prevent the spread of bacteria. For occasional use.

Dosage and administration

- Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • For personal hand hygiene to help prevent the spread of bacteria. For occasional use.

Warnings.

WARNINGS SECTION

Flammable. Keep away from open flame and sources of heat

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Supervise children when they use this product.

SPL UNCLASSIFIED SECTION

For external use only. If accidental ingestion occurs, call a Poison Control Center immediately.

Avoid contact with the eyes. If contact occurs, flush eyes with water. If irritation develops, discontinue use and consult a health care practitioner.

Directions

DOSAGE & ADMINISTRATION SECTION

- Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Carbomer, Triethanolamine, Glycerin, Aloe Barbadensis Leaf Powder, DL-alpha Tocopheryl Acetate (Vitamin E)

For domestic/personal care use.

SPL UNCLASSIFIED SECTION

Store below 43° C (110° F).

May discolour certain fabrics.

Questions :

OTC - QUESTIONS SECTION

1-844-432-6633 Mon -Fri 8am - 4pm (EST)

Email: info@eco-med.com

Package Labeling:78835-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:78835-001-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:78835-001-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:78835-001-37

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN2
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD2
2285607isopropyl alcohol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78835-001-022022-01-28C16284748780-1d6a99b39-f9af-a426-e053-dadaa90af4c2Prevent+ Gel Sanitizer
78835-001-082022-01-28C16284748780-1d6a99b39-f9af-a426-e053-dadaa90af4c2Prevent+ Gel Sanitizer
78835-001-162022-01-28C16284748780-1d6a99b39-f9af-a426-e053-dadaa90af4c2Prevent+ Gel Sanitizer
78835-001-372022-01-28C16284748780-1d6a99b39-f9af-a426-e053-dadaa90af4c2Prevent+ Gel Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78835-001-02Prevent Sanitizer60 mL in 1 BOTTLEGEL602
78835-001-08Prevent Sanitizer250 mL in 1 BOTTLEGEL2502
78835-001-16Prevent Sanitizer500 mL in 1 BOTTLEGEL5002
78835-001-37Prevent Sanitizer3785 mL in 1 JUGGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78835-001PREVENT SANITIZER (ISOPROPYL ALCOHOL) GEL [ECO-MED PHARMACEUTICALS, INC.]2Legacy NDC, 4 package rows20200811_ab97b13c-6114-25a4-e053-2995a90a90be.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
78835-00178835-001-02, 78835-001-16, 78835-001-08, 78835-001-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
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
ac8b722a-8483-2b23-e053-2a95a90a56ebab97b13c-6114-25a4-e053-2995a90a90be2020-08-10WarningsExact identifier
spl id: ac8b722a-8483-2b23-e053-2a95a90a56eb
spl set id: ab97b13c-6114-25a4-e053-2995a90a90be

Reported adverse events (FAERS/openFDA)#

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