GingiCaine Gel, Mint Julep

Benzocaine 20% w/v

Oral Anesthetic

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

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

Methemoglobinemia warning 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

Stop use and ask a doctor if (signs of toxicity)

• 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

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.

Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.

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.

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.

DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN.

Avoid excessive heat above 40°C (104°F).

polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, FD&C blue #1, D&C yellow #10

[Image in the official label — see DailyMed source]

Manufactured by: Gingi-Pak®, 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine® Mint Julep Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20116 NDC 10129-063-03 1 oz.