Forms And Presentation
Gel: Tube 15 g
Gengicure
FDA Label NDC 82160-566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Gengicure (NDC 82160-566). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding forms and presentation, active ingredient, inactive ingredients, purpose, properties, indication, precautions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
