FDA.reportPublic FDA data

Hand Sanitizer 300ml

Manufacturer
Corgiomed,LLC | Yangzhou Olande Cosmetic Co., Ltd
Effective date
2020-04-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:07:59

Label at a glance#

ProductLeafree Hand Sanitizer ALOE VERA 16.91oz
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Use as needed. No need to rinse with water. Supervise children under 6 years of age when using this product to avoid swallowing and should be supervised by an adult.

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) (80%, 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 (0.24% v/v).
  3. Triethanolamine (0.2% v/v).
  4. Sterile distilled water or boiled cold water.
  5. ALOE VERA.

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

Alcohol 70% v/vAlcohol 70% v/v Alcohol 70% v/v. Purpose: ANTIMICROBIAL

Purpose

OTC - PURPOSE SECTION

LabelLabelAntiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

LabelLabelHand 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

Warnings:

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds WarningsWarnings

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.
  • Use as needed. No need to rinse with water.
  • Supervise children under 6 years of age when using this product to avoid swallowing and should be supervised by an adult.

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, Triethanolamine, Aloe Vera, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 76573-160-18

300 ml NDC: 76573-370-05

500 ml NDC: 76573-530-09 500ml ALOE VERA500ml ALOE VERA 300ml ALOE VERA300ml ALOE VERA 100ml ALOE VERA100ml ALOE VERA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76573-160-182022-01-28C16284748780-1d6a99b39-6f76-a426-e053-dadaa90af4c2a3eaf9eb-a644-e33e-e053-2a95a90a6d14
76573-370-052022-01-28C16284748780-1d6a99b39-6f76-a426-e053-dadaa90af4c2a3eaf9eb-a644-e33e-e053-2a95a90a6d14
76573-530-092022-01-28C16284748780-1d6a99b39-6f76-a426-e053-dadaa90af4c2a3eaf9eb-a644-e33e-e053-2a95a90a6d14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76573-160-18Leafree Hand Sanitizer ALOE VERA 3.38 oz100 mL in 1 BOTTLEGEL1003
76573-370-05Leafree Hand Sanitizer ALOE VERA 10.14oz300 mL in 1 BOTTLEGEL3003
76573-530-09Leafree Hand Sanitizer ALOE VERA 16.91oz500 mL in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76573-160LEAFREE HAND SANITIZER ALOE VERA 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]3Legacy NDC, 1 package rows20200426_a3eaf9eb-a644-e33e-e053-2a95a90a6d14.zip
76573-370LEAFREE HAND SANITIZER ALOE VERA 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]3Legacy NDC, 1 package rows20200426_a3eaf9eb-a644-e33e-e053-2a95a90a6d14.zip
76573-530LEAFREE HAND SANITIZER ALOE VERA 16.91OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ (ETHYL ALCOHOL) GEL LEAFREE HAND SANITIZER ALOE VERA 10.14OZ (ETHYL ALCOHOL) GEL [CORGIOMED,LLC]3Legacy NDC, 1 package rows20200426_a3eaf9eb-a644-e33e-e053-2a95a90a6d14.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76573-16076573-160-18
76573-37076573-370-05
76573-53076573-530-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 1342809Y72KV36IACT
CUPRIC TRIETHANOLAMINE6NU949U74EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 1342809Y72KV36IACT
CUPRIC TRIETHANOLAMINE6NU949U74EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 1342809Y72KV36IACT
CUPRIC TRIETHANOLAMINE6NU949U74EIACT
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
a4239aef-b6d6-a77d-e053-2995a90ac637a3eaf9eb-a644-e33e-e053-2a95a90a6d142020-04-25WarningsExact identifier
spl id: a4239aef-b6d6-a77d-e053-2995a90ac637
spl set id: a3eaf9eb-a644-e33e-e053-2a95a90a6d14

Reported adverse events (FAERS/openFDA)#

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