Purpose
Purpose (Purpose)
Gingicaine Fusion
FDA Label NDC 10129-041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gingi-pak A Division Of The Belport for the product Gingicaine Fusion (NDC 10129-041). 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 active ingredient, purpose, allergy alert, consult a doctor, avoid excessive heat, caution, contraindications, directions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Caution
Federal Low (usa) Prohibits Dispensing Without Prescription. (Caution)
Contraindications
Should Not Be Used In Patients With History Of Hypersensitivity To Ester-type Local Anesthetics. (Contraindications)
Directions For Use
Directions For Use (Directions)
Dosage & Administration
Dosage And Administration (Dosage)
Indications
Indications (Indications)
Overdosage
Overdose (Overdose)
Precautions
Precautions (Precautions)
Uses
Uses (Uses)
Description
Description (Description)
Principal Display
Syringe_vanilla (Syringe Vanilla)
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