Gingicaine Fusion
Product Images NDC 10129-040

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Gingicaine Fusion (NDC 10129-040). 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.

FDA Label Image

Active Ingredient (Active Ingredient)

A text panel showing the active ingredient section for GingiCaine Fusion. It lists Benzocaine at a concentration of 20% weight/volume (w/v).*

FDA Label Image

Purpose (Purpose)

A drug facts panel excerpt displaying the purpose of the product: Oral Anesthetic.*

FDA Label Image

Allergy Alter (Allergy Alert)

Text panel titled 'Allergy alert' for GingiCaine Fusion, advising against use if patient has a history of allergy to any 'caine' local anesthetics, FD&C Red #40 (strawberry flavor only), PABA compounds, sunscreen, or ester-type local anesthetics. It includes warnings to consult a doctor promptly for severe sore throat or symptoms lasting more than 2 days, instructions to avoid eye contact, keep out of children's reach, and seek medical help if excessive amount is swallowed. Dosage limits are also noted.*

FDA Label Image

Consult A Doctor (Consult A Doctor)

A text panel advising to consult a doctor promptly if sore throat symptoms persist beyond two days with fever, headache, rash, nausea, or vomiting, if mouth sores do not resolve within ten days, or if irritation, pain, or redness worsens.*

FDA Label Image

Avoid Excessive Heat (Avoid Excessive Heat)

A text panel section from the product labeling containing a warning to avoid excessive heat exposure over 40°C (104°F). The information is likely part of storage or safety instructions for the product GingiCaine Fusion by Gingi-Pak a Division of the Belport.*

FDA Label Image

Caution (Caution)

This image shows a cautionary storage instruction for GingiCaine Fusion, specifying the temperature range for storage between 15 ºC (59 ºF) and 40 ºC (104 ºF). The text is simple and focused on product handling.*

FDA Label Image

Contraindications (Contraindications)

Text panel titled 'Contraindications' stating that GingiCaine Fusion should not be used in patients with a history of hypersensitivity to ester-type local anesthetics. It also advises against use for teething or in infants and children younger than 2 years.*

FDA Label Image

Indications (Indications)

A text panel section titled 'Indications' describing the use of anesthesia for oral mucous membranes to reduce pain and discomfort during dental procedures such as ulcers, needle punctures, deep scaling, application of matrix bands, and aiding in dental impressions or intraoral radiographs in patients with excessive gag reflex.*

FDA Label Image

Directions For Use (Directions)

A directions for use panel for GingiCaine Fusion by Gingi-Pak a Division of the Belport. It provides step-by-step instructions for applying the gel to targeted mucosal areas, including steps for preparing the syringe, attaching the micro needle tip, applying gel to periodontal pockets, maintaining the gel position for one minute, spitting out excess, and disposing of used materials safely.*

FDA Label Image

Dosage And Administration (Dosage)

A drug facts or directions label panel for GingiCaine Fusion by Gingi-Pak a Division of the Belport. This section provides dosage and administration instructions, including drying the targeted mucosal area, applying the gel with sterile cotton or gauze, allowing the gel to remain for at least one minute, and precautions such as limiting application to four times daily and avoiding cross-contamination. It also notes use for adults and children 2 years or older.*

FDA Label Image

Inactive Ingredients (Inactive Ingredients)

Text panel listing the inactive ingredients of GingiCaine Fusion, including polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, hemp extract, flavor, and FD&C Red #40 (strawberry only).*

FDA Label Image

Keep Out Of Reach Of Children (Keep Out Of Reach Of Children)

Text panel displaying a safety warning: "Keep out of reach of children." This panel likely contains precautionary information related to GingiCaine Fusion.*

FDA Label Image

Overdose (Overdose)

A text panel warning about accidental swallowing of more than the normal usage amount of GingiCaine Fusion. It advises seeking medical help or contacting a Poison Control Center immediately and cautions not to exceed the recommended dosage.*

FDA Label Image

Precautions (Precautions)

A precautionary text panel advising dentists to avoid applying the product to severely traumatized mucosal areas or posterior pharynx regions that could affect protective reflexes. It warns about cautious use in patients with known sensitivities to ester-type anesthetics like procaine, benzocaine, and tetracaine, and advises dentists to avoid contact with all local anesthetics to prevent sensitization.*

FDA Label Image

Temper Evident Statement (Temper Evident Sleeve)

A warning text panel stating, "DO NOT USE IF TEMPER-EVIDENT SLEEVE IS BROKEN." indicating safety instructions regarding tamper-evident packaging for the product GingiCaine Fusion by Gingi-Pak a Division of the Belport.*

FDA Label Image

Uses (Uses)

Drug facts text panel focusing on the uses of GingiCaine Fusion, describing it as reducing pain or discomfort caused by minor dental procedures such as scaling and root planing, minor gum injury, canker sores, sore throat, and minor irritation caused by dentures or orthodontic appliances, as well as reducing discomfort during mucous membrane healing.*

FDA Label Image

Warnings (Warnings)

Warning text panel for GingiCaine Fusion containing safety information about risk of methemoglobinemia with symptoms to watch for and an age restriction indicating it should not be used in children under 2 years.*

FDA Label Image

Description (Description)

A text panel describing GingiCaine Fusion as a local anesthetic for topical application, containing 20% benzocaine gel infused with 2% hemp extract in a flavored polyethylene glycol base sweetened with saccharin.*

FDA Label Image

Jar Label_vanilla (Jar Label Vanilla)

GingiCaine Fusion 20% Benzocaine with 2% Hemp Extract infused topical gel label by Gingi-Pak, a Division of the Belport. The label indicates a net weight of 0.5 oz (14 grams) and vanilla scent. Manufacturer address and contact details are included. The NDC number is 10129-040-01.*

FDA Label Image

Jar Box_vanilla (Jar Box Vanilla)

Packaging label for GingiCaine Fusion infused topical gel by Gingi-Pak a Division of the Belport. The product contains 20% benzocaine with 2% hemp extract and comes in a 0.5 oz (14 gm) size. The label features a green accent background, vanilla flavor, and usage warnings and descriptions, including methemoglobinemia warnings and product application details.*

FDA Label Image

Syringe_vanilla (Syringe Vanilla)

GingiCaine Fusion Vanilla Infused Topical Gel label showing the product name, volume of 1.2 mL, and usage warning not for injection and to destroy after use. The label includes lot number 105-156, expiry date 05/2023, and identifies the labeler as Gingi-Pak, a Division of the Belport, made in the USA.*

FDA Label Image

Jar Label_strawberry (Jar Label Stawberry)

The packaging label for GingiCaine Fusion Infused Topical Gel features the product name prominently, indicating it contains 20% Benzocaine with 2% Hemp Extract. It is strawberry flavored with a net weight of 0.5 oz (14 gm). Manufactured by Gingi-Pak, a division of Belport, it includes contact information and a QR code on the left side of the label.*

FDA Label Image

Jar Box_strawberry (Jar Box Strawberry)

GingiCaine Fusion packaging label showing a red and white design with strawberry imagery. The product is a 0.5 oz (14 gm) infused topical gel containing 20% benzocaine with 2% hemp extract. The label includes warnings, usage description, and is labeled by Gingi-Pak, a Division of the Belport, made in USA. It also features the NDC #10129-041-01.*

FDA Label Image

Sryringe_strawberry (Syringe Stawberry)

GingiCaine Fusion Strawberry Infused Topical Gel label showing 1.2 mL volume. The label states it is not for injection and to destroy after use. It is made by Gingi-Pak, a division of Belport, in the USA. The label includes reference and lot numbers and an expiration date of 05/2023.*

FDA Label Image

Box Package (Box Package)

Label for GingiCaine Fusion topical anesthetic gel containing 20% benzocaine and 2% hemp extract. The label indicates quick 15-20 second onset, up to 30 minutes anesthesia, immediate pain relief, and patient friendly flavor. Manufactured by Gingi-Pak with address in Camarillo, CA, this package contains 0.81 oz. (24 mL) and 20 syringes with tips. Made in USA.*

* 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.