Purpose
Purpose (Purpose)
Gingicaine Fusion
FDA Label NDC 10129-040
13 label sections · Submitted to the FDA by Gingi-pak A Division Of The Belport · 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 10129-040). 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
Caution (Caution)
Contraindications
Contraindications (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)
Warnings
Warnings (Warnings)
Description
Description (Description)
Recent Major Changes
- Indications section was NOT modified and remains the same as the previous label
- Contraindications section was modified, such that the statement "do not use product for teething or in infants and children younger than 2" was added. This change was made effective on 12/07/2021.
- Caution section was modified, such that the previous statement was replaced with "store between 15 C (59 F) and 40 C (104 F).
- Uses section was madified, such that the statement "Reduces discomfort during healing process of mucous membrane," was added to pervious statement, effective 12/07/2021
- Warning section was modified, such that the defenition of methemoglobinemia is added to the statement, effective 12/07/2021.
- Jar Box_Strawberry, Jar Box_Vanilla, Jar Label_Strawberry, Jar label_Vanilla, Syringe_Strawberry, and Syringe_Vanilla sections were all updated with new label corrections, effective 12/07/2021
Principal Display
Syringe_vanilla (Syringe Vanilla)
Sryringe_strawberry (Syringe Stawberry)
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