Gingicaine Gel
Product Images NDC 10129-035

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Gingicaine Gel (NDC 10129-035). 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)

Warning text panel for Gingicaine Gel instructing to keep the product out of reach of children and to call a doctor immediately if the gel is ingested or swallowed by a child, following directions accordingly.*

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Contraindications

This text panel presents the contraindications for Gingicaine Gel 200 mg/1, emphasizing that it should not be used in patients with known hypersensitivity to ester-type local anesthetics or for teething in infants and children under 2 years of age.*

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Gingicaine Banana Jar Label

Drug Facts and product label for Gingicaine Gel 20% Benzocaine Oral Anesthetic 1 oz (30 gm) by Gingi-Pak. Panels include active ingredient, uses, allergy alert, warnings, directions, dosage and administration, and manufacturer information. The label also features the flavor as Banana and product NDC 10129-035-03.*

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Active Ingredients (Gingicaine Active Ingredients 001)

A text panel listing the active ingredient Benzocaine 20% w/v in Gingicaine Gel as an oral anesthetic. The panel clearly separates the active ingredient and its purpose with headings for 'Active ingredient' and 'Purpose.'*

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Allergy Alert002 (Gingicaine Allergy Alert 002)

A warning text panel titled Allergy alert advising not to use the product if there is a history of allergy to any 'caine' local anesthetics.*

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Avoid Excessive Heat (Gingicaine Avoid Excessive Heat)

A text panel titled 'Avoid Excessive heat' advises to keep the product above 40 degrees Celsius (104 degrees Fahrenheit) to prevent damage or degradation. The warning is presented in bold and standard font.*

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Consult A Doctor Promptly (Gingicaine Consult A Doctor)

A text panel providing warnings and precautions for Gingicaine Gel 200 mg/1. It advises consulting a doctor if severe sore throat persists over 2 days or is accompanied by specific symptoms, if mouth sore does not heal in 10 days, or if irritation worsens. It cautions to avoid eye contact, keep out of children’s reach, and seek medical help if large amounts are swallowed. It also warns not to exceed recommended dosage.*

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Dosage And Administration001 (Gingicaine Dosage And Admin 001)

A partial text panel titled 'Dosage & Administration' instructing that the mucosa should be dried prior to application and mentioning the removal of excess saliva. The text is incomplete.*

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Dosage And Administration002 (Gingicaine Dosage And Admin 002)

Text panel containing directions for use of Gingicaine Gel 200 mg/1, a local anesthetic product. It includes instructions on applying to the affected area, dosage limits, precautions to minimize dilution and cross-contamination, and age recommendations for use.*

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Indication (Gingicaine Indications 001)

A text panel titled Indications describing the use of Gingicaine Gel for anesthesia of mucous membranes in the oropharynx. It states the gel minimizes pain from ulcers, needle punctures, deep scaling, and matrix band application, and aids in taking impressions or intraoral radiographs for patients with excessive gag reflex.*

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Precautions (Gingicaine Precaution 001)

A drug facts panel labeled "Precautions" advising dentists to avoid applying Gingicaine Gel to severely traumatized mucosal areas or areas of the posterior pharynx that could suppress protective reflexes. The panel includes cautions for use in patients sensitive to ester-type anesthetics and warns against contact to prevent sensitization.*

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Uses (Gingicaine Uses 001)

Drug Facts panel section titled 'Uses' lists conditions treated by the product, including 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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Gingicaine Gel Banana-hakusui (Gingicaine Gel Label Jpn Eng)

Label for Gingicaine Gel 20%, a 30g topical anesthetic gel for dental use with banana flavor. The label is predominantly yellow and white with blue and black text, showing the product name in Japanese and English. Manufactured by Gingi-Pak, a division of Belport Co., Inc., with marketing authorization holder Hakusui Trading Co., Ltd., Osaka, Japan. The label includes active ingredient information, medical drug approval number, and space for manufacturing lot and expiry dates.*

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Inactive Ingredient (Inactive Ingredient Page 001)

A text panel listing inactive ingredients for Gingicaine Gel. The visible inactive ingredients include Polyethylene Glycol 3350, Polyethylene Glycol 400, and Potassium Sodium Saccharate. No other product or instruction text is visible in the image.*

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Purpose (Purpose Page 001)

Text describing Gingicaine Gel as a topical anesthetic used by dentists just prior to an injection, typically applied to a patient's gum. The text is a simple explanatory note, not detailed product labeling.*

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Warnings

A warning text panel advising that Gingicaine Gel is for external use only and may cause methemoglobinemia, a serious condition reducing blood oxygen. It instructs to stop use and seek medical attention if symptoms like cyanosis, headache, rapid heart rate, shortness of breath, dizziness, or fatigue occur. It also warns not to use in 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.