FDA.reportPublic FDA data

Medart Hand Sanitizer Gel

Manufacturer
Chengdu MedArt Medical Scientific CO., LTD.
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:58

Label at a glance#

ProductMedart Hand Sanitizer Gel
Active ingredientALCOHOL
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

Alcohol 75 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

glycerin, cabomer, purified water USP, ethylhexyl glycerol, glycerol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 78861-001-01 11
50 mL NDC: 78861-001-02 22
100 mL NDC: 78861-001-03 33
200 mL NDC: 78861-001-04 44
250 mL NDC: 78861-001-05 55
450 mLN DC: 78861-001-06 66
500 mL NDC: 78861-001-07 77
1000 mL NDC: 78861-001-08 77
2000 mL NDC: 78861-001-09 99
5000 mL NDC: 78861-001-10 1010
60 mL NDC: 78861-001-11 1111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78861-001-012023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-022023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-032023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-042023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-052023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-062023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-072023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-082023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-092023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-102023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a
78861-001-112023-01-30C16284748780-1f386c649-d5a5-0266-e053-dadaa90a7c1aa81eda33-0df1-0cf6-e053-2995a90a752a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78861-001-01Medart Hand Sanitizer Gel30 mL in 1 BOTTLEGEL302
78861-001-02Medart Hand Sanitizer Gel50 mL in 1 BOTTLEGEL502
78861-001-03Medart Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1002
78861-001-04Medart Hand Sanitizer Gel200 mL in 1 BOTTLEGEL2002
78861-001-05Medart Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2502
78861-001-06Medart Hand Sanitizer Gel450 mL in 1 BOTTLEGEL4502
78861-001-07Medart Hand Sanitizer Gel500 mL in 1 BOTTLEGEL5002
78861-001-08Medart Hand Sanitizer Gel1000 mL in 1 BOTTLEGEL10002
78861-001-09Medart Hand Sanitizer Gel2000 mL in 1 BOTTLEGEL20002
78861-001-10Medart Hand Sanitizer Gel5000 mL in 1 BOTTLEGEL50002
78861-001-11Medart Hand Sanitizer Gel60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78861-001MEDART HAND SANITIZER GEL (ALCOHOL) GEL [CHENGDU MEDART MEDICAL SCIENTIFIC CO., LTD.]2Legacy NDC, 11 package rows20211119_a81eda33-0df1-0cf6-e053-2995a90a752a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78861-00178861-001-01, 78861-001-02, 78861-001-03, 78861-001-04, 78861-001-05, 78861-001-06, 78861-001-07, 78861-001-08, 78861-001-09, 78861-001-10, 78861-001-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
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
d1089ccb-f221-1e48-e053-2a95a90a12c7a81eda33-0df1-0cf6-e053-2995a90a752a2021-11-17WarningsExact identifier
spl id: d1089ccb-f221-1e48-e053-2a95a90a12c7
spl set id: a81eda33-0df1-0cf6-e053-2995a90a752a

Reported adverse events (FAERS/openFDA)#

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