Active Ingredient
Benzocaine 20% w/v
Gingicaine Gel
FDA Label NDC 10129-035
11 label sections · Submitted to the FDA by Gingi-pak A Division Of The Belport · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gingi-pak A Division Of The Belport for the product Gingicaine Gel (NDC 10129-035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, allergy alert and contraindication, stop use and ask a doctor if, purpose, keep out of reach of children, dosage and administration, indications and uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, D&C Yellow #10
Allergy Alert And Contraindication
Do not use if you have a history of allergy to any “Caine” local anesthetics.
Avoid contact with eyes.
Keep out of reach of children.
If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
Stop Use And Ask A Doctor If
Ask a doctor before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obstruct protective reflexes.
Purpose
Oral Anesthetic
Keep Out Of Reach Of Children
Keep out of reach of children.
If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Dosage And Administration
Mucosa should be dried prior to application.
Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic.
Sterile cotton or gauze should be used in applying anesthetic to mucosa.
Care must be taken to avoid cross–contamination between patients.
Total dose should not exceed the amount required for anesthesia.
Apply to the affected area. Remain in place for at least 1 minute and then spit out.
• Use up to 4 times a day or as directed by a dentist or doctor.
• This product is for adults and children 2 years of age and older.
Indications And Uses
For anesthesia of mucous membrane of oropharynx.
Temporary relief of pain or discomfort caused by
• Minor dental procedures
• Minor gum injury
• canker sores
• Sore throat
• Minor mouth or gum irritations caused by dentures or orthodontic appliances
Avoid Excessive Heat
DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN.
Avoid excessive heat above 40°C (104°F).
Warnings
Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age.
For topical use only
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop:
• Pale, gray, or blue colored skin (cyanosis)
• Headache
• Rapid heart rate
• Shortness of breath • Dizziness or lightheadedness
• Fatigue or lack of energy
Sore throat is severe and more than 2 days
Fever, headache, rash, nausea, or vomiting develops
Mouth sores do not go away in 7 days
Irritation, pain, or redness worsens
Gingicaine Gel Banana Label
Manufactured by: Gingi-Pak®, 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine® Banana Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20113 NDC 10129-035-03 1 oz.
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