FDA.reportPublic FDA data

LECHAT Sanitizer Gel

Manufacturer
Mega Creation Inc.
Effective date
2022-10-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:11

Label at a glance#

ProductLECHAT
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with the product and rub it on the skin untill dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30 C (59-86F) Avoid freezing & excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria.

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

  • Wet hands thoroughly with the product and rub it on the skin untill dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30 C (59-86F)
  • Avoid freezing & excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water, isopropyl alcohol, hydroxypropyl methylcellulose, dl alpha-tocopheryl acetate, Aloe barbadensis leaf extract, Lavandula Angustifolia oil, citrus Aurantium Dulcis peel, citrus paradisi peel oil, Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60mL NDC: 77857-812-0260mL NDC: 77857-812-0260mL NDC: 77857-812-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN4
902574ethanol 0.65 ML/ML Topical GelSCD4
902574ethyl alcohol 65 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77857-812-012023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-022023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-042023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-082023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-162023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-282023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel
77857-812-322023-07-28C16284748780-10191ceaa-6e26-198a-e063-dbdaa90aec3eLECHAT Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77857-812-01LECHAT51 mL in 1 BOTTLEGEL514
77857-812-02LECHAT60 mL in 1 BOTTLEGEL604
77857-812-04LECHAT118 mL in 1 BOTTLEGEL1184
77857-812-08LECHAT236 mL in 1 BOTTLEGEL2364
77857-812-16LECHAT473 mL in 1 BOTTLEGEL4734
77857-812-28LECHAT3780 mL in 1 BOTTLEGEL37804
77857-812-32LECHAT946 mL in 1 BOTTLEGEL9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77857-812LECHAT (HAND SANITIZER GEL) GEL [MEGA CREATION INC.]4Legacy NDC, 7 package rows20221027_af0c37c2-31d4-7583-e053-2a95a90a3306.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77857-81277857-812-01, 77857-812-02, 77857-812-04, 77857-812-08, 77857-812-16, 77857-812-32, 77857-812-28

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
HYPROMELLOSES3NXW29V3WOIACT
CITRUS PARADISI FRUIT OIL6A7N43E0OJIACT
LAVENDER OILZBP1YXW0H8IACT
ORANGE PEELTI9T76XD44IACT
FRAGRANCE GREEN APPLE ORC2001072U9GH30P956IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ISOPROPYL ALCOHOLND2M416302IACT

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
ebce60ec-3482-3897-e053-2a95a90a00d0af0c37c2-31d4-7583-e053-2a95a90a33062022-10-24WarningsExact identifier
spl id: ebce60ec-3482-3897-e053-2a95a90a00d0
spl set id: af0c37c2-31d4-7583-e053-2a95a90a3306

Reported adverse events (FAERS/openFDA)#

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