Uses
Reduce 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.
Ultracare Anesthetic Gel
FDA Label NDC 10129-072
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Belport Company, Inc. Dba Gingi-pak for the product Ultracare Anesthetic Gel (NDC 10129-072). 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 uses, adverse reactions, otc - active ingredient, otc - keep out of reach of children, otc - do not use, otc - ask doctor/pharmacist, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Benzocaine 20% W/v (Api)
Otc - Keep Out Of Reach Of Children
Keep Out Of Reach Of Children (Children)
Otc - Do Not Use
Do Not Use In Patients With History Of Ypersensitivity To Any Ester-type Local Anesthetics. Do Not Use The Product For Teething Or In Infants And Children Younger Than 2 Years (Dnu)
Dnu (Dnu2)
Otc - Ask Doctor/Pharmacist
Consult (Consult)
Ask doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharnx that might obtund protective reflexes. Stop use and ask doctor if sore throat is severe for more than 2 days, fever, headache, rash, nausea, or vomiting develops, mouth sore does not go away within 10 days, irritation, pain or redness worsens.
Dosage & Administration
Dose Admin (Doseadmin)
Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anethestic. Sterile cotton or gause 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 minutes and then spit. Use up to 4 times daily or as directed by dentist or doctor. Do not exceed recommended dosage. This product is for adults and children 2 years or age and older. Children under 2 years of age should consult a dentist or a doctor.
Inactive Ingredient
Inactive (Inactive)
The inactive ingredients in UltraCare bubblegum are polyethylene glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3350) NF, Sodium Saccharin, artificial Flavor, FD$C Red #40.
Warnings
Warnings (Warnings)
Safe Handling Warning
Storage (Storage)
Package Label.Principal Display Panel
Facts (Drugfacts2)
Facts (Drugfacts1)
Lable (Label)
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