Gingicaine Gel, Cotton Candy Flavor
Product Images NDC 10129-037

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gingicaine Gel, Cotton Candy Flavor (NDC 10129-037). 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 a warning about the Gingicaine Gel products, advising individuals to keep them away from children to avoid ingestion or swallowing, which may require immediate medical attention.*

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Contraindications

This text provides important information about the contraindications of using ester-type local anesthetics. It warns against using this product on patients who have a history of hypersensitivity to these anesthetics. Additionally, it advises against using the product for teething or on infants and children under the age of 2.*

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Gingicaine Cotton Candy Jar Label

Pumose is an oral anesthetic gel containing 20% benzocaine. It is used to reduce pain and discomfort caused by minor dental procedures, gum injuries, canker sores, sore throat, and mouth irritations caused by dentures or orthodontic appliances. It should not be used if the patient has a history of allergy to local anesthetics or FD&C Red #40. The product contains warnings and directions for use, including avoiding excessive heat and not exceeding the recommended dosage. It is for external use only and should be kept out of reach of children. The gel is manufactured by Gingi-Pak in the USA.*

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Active Ingredients (Gingicaine Active Ingredients 001)

Benzocaine is an active ingredient that is used as an oral anesthetic, providing relief from pain and discomfort in the mouth. It is present in a concentration of 20% w/v which is effective in providing localized pain relief.*

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Allergy Alert (Gingicaine Allergy Alert 001)

This is a warning statement that states that a product should not be used if the user has a history of allergy to any "caine" local anesthetics or FD&C Red #40.*

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Avoid Excessive Heat (Gingicaine Avoid Excessive Heat)

This text is a warning message about avoiding excessive heat above a certain temperature limit of 40 °C (104 °F).*

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Consult A Doctor (Gingicaine Consult A Doctor)

This text is a warning about the use of a product that can cause harm if used improperly. It advises to consult a doctor in case of severe sore throat, fever, headache, rash, nausea or vomiting, and if mouth sore does not go away within 10 days. It warns to avoid contact with eyes, keep out of reach of children, and seek medical help or contact Poison Control Center immediately if more than normal usage amount is accidentally swallowed. It also cautions not to exceed recommended dosage.*

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Dosage And Adminnstration001 (Gingicaine Dosage And Admin 001)

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Dosage And Adminnstration002 (Gingicaine Dosage And Admin 002)

This text provides instructions for administering local anesthesia using cotton rolls or saliva ejectors to minimize dilution. It emphasizes the importance of using sterile cotton or gauze to prevent cross-contamination between patients, and warns against exceeding the recommended dosage. The anesthesia should remain in the affected area for at least one minute before being split out, and the product is suitable for adults and children aged two or above, with younger children advised to consult a dentist or doctor.*

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Indications (Gingicaine Indications 001)

This text describes the medical application and usage of a product that anesthetizes the mucous membranes of the oropharynx, reducing pain associated with various dental procedures such as ulcers, needle punctures, deep scaling, and the application of matrix bands. It also serves as an aid in the taking of impressions or intraoral radiographs for patients who experience a strong gag reflex.*

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Precautions (Gingicaine Precaution 001)

This text provides precautions for dentists when using local anesthetics. It advises against applying them to severely traumatized, infected mucosal areas or areas of the posterior pharynx that may impact protective reflexes. It also cautions dentists to use these anesthetics carefully in patients with known drug sensitivities or allergies to ester-type anesthetics. Finally, it recommends that dentists avoid contact with all local anesthetics to prevent possible sensitization.*

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Uses (Gingicaine Uses 001)

This text describes the uses of a product to reduce pain or discomfort caused by various dental issues such as 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 chemical compounds commonly used in various industries including pharmaceuticals and personal care products due to their solubility and viscosity properties. They are also used as laxatives for bowel preparation before medical procedures. Potassium Sodium Saccharate is a sweetener and flavor enhancer used primarily in food and beverages.*

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Purpose (Purpose Page 001)

Gingicaine Gel is a topical anesthetic applied by dentists before administering injections. It is spread on the patient's gum for numbing purposes.*

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Warnings

This text is a warning for a product and advises that it is only for external use. The product may cause a rare but serious condition called methemoglobinemia, which reduces the amount of oxygen in the blood. If symptoms such as pale skin, headache, rapid heart rate, shortness of breath, dizziness, lightheadedness, fatigue, or lack of energy appear, medical attention should be sought immediately, and the use of the product should be stopped. The product should not be used in children under two years old.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.