Gengicure

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
566
Source
full-release
Hydrated at
2026-05-31 23:45:32

Label at a glance#

ProductGengicure
Active ingredientHYALURONIC ACID
Label structure16 sections

Dosage and administration

Apply a film of gel onto affected area only, massaging gently with clean fingers to aid its correct distribution and then keep it to dry for 30 – 60 seconds. Apply 2-3 times daily, for one week or until the symptoms disappear. It is advisable not to eat or drink for at least 30 minutes after application.

Storage and handling

Store below 30 ◦ C.

Label contents#

Full prescribing information#

Forms and Presentation

HOW SUPPLIED SECTION

Gel: Tube 15 g

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hyaluronic Acid

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Hydroxypropyl Cellulose, Sodium Benzoate and Dichlorobenzyl Alcohol.

Purpose

OTC - PURPOSE SECTION

Helps healing internal and external mouth ulcers and relieving pain

Properties

DESCRIPTION SECTION

gengicure® gel has a special formula immediately reduces pain and promotes the treatment of oral mucosal ulcers by accelerating normal healing process because it contains hyaluronic acid, a natural substance found in the connective tissues of the body. When applied to the ulcers it stimulates the production of new healthy tissue.
Paraben Free
Sugar Free
Colorants Free

Indication

INDICATIONS & USAGE SECTION

gengicure ®gel helps healing internal and external mouth ulcers and relieving pain

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

  • Do not swallow the product
  • If symptoms persist consult your doctor

Contraindication

CONTRAINDICATIONS SECTION

  • Hypersensitivity to any of the components
  • Do not use for children under 2 years

Pregnancy and Lactation

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask your doctor or pharmacist for advice before using any product.
If you want to apply the gel during pregnancy or lactation then discuss this with your doctor

Interactions

DRUG INTERACTIONS SECTION

No interactions between gengicure ® gel and other drugs or substances are known or suspected.

Side effects

ADVERSE REACTIONS SECTION

There are no known side effects

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply a film of gel onto affected area only, massaging gently with clean fingers to aid its correct distribution and then keep it to dry for 30 – 60 seconds.
Apply 2-3 times daily, for one week or until the symptoms disappear.
It is advisable not to eat or drink for at least 30 minutes after application.

Storage Conditions

STORAGE AND HANDLING SECTION

Store below 30 ◦C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-566-01Gengicure15 g in 1 TUBEGEL15566
82160-566-01Gengicure1 in 1 CARTONGEL1566

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-566GENGICURE (HYALURONIC ACID) GEL [PELLA PHARMACEUTICALS CO. LTD]566Legacy NDC, 2 package rows20211209_d27a5bb1-59e0-77ce-e053-2a95a90a7678.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-56682160-566-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
d27a5bb1-59e1-77ce-e053-2a95a90a7678d27a5bb1-59e0-77ce-e053-2a95a90a76782021-12-06Warnings, Adverse reactionsExact identifier
spl id: d27a5bb1-59e1-77ce-e053-2a95a90a7678
spl set id: d27a5bb1-59e0-77ce-e053-2a95a90a7678

Reported adverse events (FAERS/openFDA)#

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