Gingicaine Fusion

SPL v2

SPL

SPL Set ID a1f3c4d4-048c-7c3c-e053-2995a90a1b35

Routes

TOPICAL DENTAL

Published

Effective Date 2021-12-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (24 g)

Inactive Ingredients

Polyethylene Glycol 3350 Cannabidiol Polyethylene Glycol 400 Potassium Sodium Saccharate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-06-04

Description

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

Medication Information

Purpose

Contraindications

Description

Uses

Section 43683-2

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

Caution

Warnings

Overdosage

Indications

Precautions

Allergy Alert

Consult A Doctor

Active Ingredient

Principal Display

Directions for Use

Avoid Excessive Heat

Inactive Ingredients

Dosage & Administration

Temper Evident Statement

Keep Out of Reach of Children

Structured Label Content

Uses

Section 43683-2 (43683-2)

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

Caution

Purpose

Warnings

Overdosage

Description

Indications

Precautions

Allergy Alert

Consult A Doctor (Consult a doctor)

Active Ingredient

Contraindications

Principal Display

Directions for Use

Avoid Excessive Heat (Avoid Excessive heat)

Inactive Ingredients

Dosage & Administration

Temper Evident Statement

Keep Out of Reach of Children (Keep out of reach of children)

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "24", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CANNABIDIOL", "unii": "19GBJ60SN5", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "52", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POTASSIUM SODIUM SACCHARATE", "unii": "73U34YC90U", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "24", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CANNABIDIOL", "unii": "19GBJ60SN5", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POTASSIUM SODIUM SACCHARATE", "unii": "73U34YC90U", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "52", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"43683-2": "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:51.629825 · Updated: 2026-03-14T23:00:00.825932