GENGICURE- hyaluronic acid gel

Gengicure by

Drug Labeling and Warnings

Gengicure by is a Otc medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Forms and Presentation

Gel: Tube 15 g

Active Ingredient

Hyaluronic Acid

Inactive Ingredients

Aqua, Hydroxypropyl Cellulose, Sodium Benzoate and Dichlorobenzyl Alcohol.

Purpose

Helps healing internal and external mouth ulcers and relieving pain

Properties

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

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

Precautions

Keep out of reach of children

Warnings

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

Contraindication

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

Pregnancy and Lactation

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

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

Side effects

There are no known side effects

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 Conditions

Store below 30 ◦C.

Primary Package

Secondary Package

INGREDIENTS AND APPEARANCE

GENGICURE 
hyaluronic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONIC ACID	0.3 mg  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-566-01	1 in 1 CARTON	01/15/2020
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/15/2020

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)