Gingicaine Gel, Pina Colada Gel
Product Images NDC 10129-033

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gingicaine Gel, Pina Colada (NDC 10129-033). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gingi-pak A Division Of The Belport, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Keep Out Of Reach Of Children (Children Page 001)

This text provides important safety information regarding Gingicaine Gel products, advising to keep them out of reach of children and to seek medical attention immediately if a child ingests or swallows Gingicaine.*

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Contraindications

This text is a warning for the usage of a certain product. It states that the product should not be used by patients with a history of hypersensitivity to ester-type local anesthetics. It also warns against using the product for teething or on children under the age of 2.*

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Gingi Caine Pina Colada Jar Label

This is a 20% Benzocaine gel used as a topical oral anesthetic to relieve pain or discomfort caused by minor dental procedures, gum injuries, canker sores, sore throat, mouth or gum irritations from dentures or orthodontic appliances. It warns potential users to avoid usage if they have a history of allergy to local anesthetics or FD&C Red #40, caused by excessive heat or if sleeve is broken. The anesthetic should not be used in children under 2 years and dentists should avoid applying it to severely traumatized or infected mucosal areas, or those of the posterior pharynx. Directions for use includes the drying of mucosa prior to application, and cotton or gauze should be used to apply anesthetic. The product is for adults and children 2 years of age and older.*

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Active Ingredients (Gingicaine Active Ingredients 001)

Benzocaine is an oral anesthetic and the active ingredient in the product.*

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Allergy Alert (Gingicaine Allergy Alert 001)

This text is a warning label for a product stating that it should not be used by individuals with a history of allergy to local anesthetics containing "caine" or FD&C Red #40.*

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Avoid Excessive Heat (Gingicaine Avoid Excessive Heat)

This text provides a cautionary statement advising to avoid exposing something to temperatures above 40°C (104°F), as excessive heat may cause damage or harm.*

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Consult A Doctor Promptly (Gingicaine Consult A Doctor)

This text provides instructions and warnings for using a product, potentially a medication, to treat sore throat and mouth sores. It advises seeking prompt medical attention if symptoms persist or are accompanied by certain other symptoms. The product should be kept away from children and not swallowed in excess of the recommended dosage. Users should also avoid contact with their eyes.*

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Dosage And Adminstration001 (Gingicaine Dosage And Admin 001)

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Dosage And Adminstration002 (Gingicaine Dosage And Admin 002)

This is a set of instructions and precautions for using local anesthetic in dental procedures. The text advises using cotton or saliva ejectors to avoid dilution of the anesthetic, using sterile cotton or gauze to apply the anesthetic, and taking care to avoid cross-contamination between patients. The total dose should be no more than necessary, and the anesthetic should be applied to the affected area for at least 1 minute. The product can be used up to 4 times daily, but recommended dosage should not be exceeded. The anesthetic is suitable for adults and children over 2 years old, but younger children should consult a dentist or doctor.*

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Indications (Gingicaine Indications 001)

The text describes the indications for using anesthesia of mucous membranes in the oropharynx to minimize pain during various dental procedures such as ulcers, needle puncture, deep scaling procedures, and the application of matrix bands. It can also be used as an aid for taking impressions or intraoral radiographs of patients with an excessive gag reflex.*

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Precautions (Gingicaine Precaution 001)

This text provides precautions and guidelines for dentists to follow when administering local anesthetics. It warns against applying anesthetics to severely traumatized or infected mucosal areas, as well as areas that may affect protective reflexes. It also advises caution when using anesthetics on patients with known drug sensitivities, specifically to ester-type anesthetics like procaine, benzocaine, and tetracaine. Additionally, dentists should avoid any contact with anesthetics to prevent sensitization.*

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Uses (Gingicaine Uses 001)

This is a description of a product that can be used to reduce pain or discomfort caused by minor dental procedures, minor gum injury, canker sores, sore throat, and minor mouth or gum irritations caused by dentures or orthodontic appliances.*

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Inactive Ingredients (Inactive Ingredient Page 001)

Polyethylene Glycol 3350 and Polyethylene Glycol 400 are both chemicals commonly used as laxatives to treat constipation. They work by retaining water in the stool, making it easier to pass. Potassium Sodium Saccharate is a sweetener and flavor enhancer used in food and beverage products.*

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Purpose (Purpose Page 001)

Gingicaine Gel is a topical anesthetic used by dentists to numb the gums before an injection. This gel is applied to the patient's gum for this purpose.*

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Warnings

This is a warning for a product stating that it is for external use only. It also mentions that the use of the product may cause a rare but serious condition called methemoglobinemia, which reduces the amount of oxygen carried in the blood. The text advises users to seek immediate medical attention if symptoms like pale, gray or blue colored skin, headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy develop after use. Not to be used on children under 2 years of age.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.