FDA.reportPublic FDA data

Leafree Hand Sanitizer 10.14oz

Manufacturer
Corgiomed,LLC
Effective date
2020-04-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:08:07

Label at a glance#

ProductLeafree Hand Sanitizer 16.91oz
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Use as needed. No need to rinse with water For children under 6 years of age, use only under adult supervision. Not recommender for infants

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Carbomer
  3. Trolamine
  4. Sterile distilled water or boiled cold water.

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

activeactiveEthyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer 500ML500ML

Use

INDICATIONS & USAGE SECTION

Uses:
Hand Sanitizer, reduce bacteria on the skin
Recommend for repeated use

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from heat, fire or flame

Warnings:

OTC - DO NOT USE SECTION

500ml500mlDo not use Children less than 2 months of age on open skin wounds
Keep out of reach of children. If swallowed, get medical help or contact a poison Central right away

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

Directions:
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Use as needed. No need to rinse with water
For children under 6 years of age, use only under adult supervision.
Not recommender for infants

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, TROLAMINE, WATER.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ML500ML300ML300ML100ML100ML100 mL NDC:76573-170-19

300 ml NDC: 76573-390-16

500 ml NDC: 76573-550-09

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76573-170-192022-01-28C16284748780-1d6a99b39-f128-a426-e053-dadaa90af4c2a42ecc76-ddbe-b074-e053-2a95a90ae9a2
76573-390-162022-01-28C16284748780-1d6a99b39-f128-a426-e053-dadaa90af4c2a42ecc76-ddbe-b074-e053-2a95a90ae9a2
76573-550-092022-01-28C16284748780-1d6a99b39-f128-a426-e053-dadaa90af4c2a42ecc76-ddbe-b074-e053-2a95a90ae9a2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76573-170-19Leafree Hand Sanitizer 3.38oz100 mL in 1 BOTTLEGEL1004
76573-390-16Leafree Hand Sanitizer 10.14oz300 mL in 1 BOTTLEGEL3004
76573-550-09Leafree Hand Sanitizer 16.91oz500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76573-170LEAFREE HAND SANITIZER 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 3.38OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]4Legacy NDC, 1 package rows20200427_a42ecc76-ddbe-b074-e053-2a95a90ae9a2.zip
76573-390LEAFREE HAND SANITIZER 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 3.38OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]4Legacy NDC, 1 package rows20200427_a42ecc76-ddbe-b074-e053-2a95a90ae9a2.zip
76573-550LEAFREE HAND SANITIZER 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 3.38OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]4Legacy NDC, 1 package rows20200427_a42ecc76-ddbe-b074-e053-2a95a90ae9a2.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
76573-55076573-550-09
76573-17076573-170-19
76573-39076573-390-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9804Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a42ef5a0-da97-643a-e053-2995a90ac3dea42ecc76-ddbe-b074-e053-2a95a90ae9a22020-04-26WarningsExact identifier
spl id: a42ef5a0-da97-643a-e053-2995a90ac3de
spl set id: a42ecc76-ddbe-b074-e053-2a95a90ae9a2

Reported adverse events (FAERS/openFDA)#

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