FDA Label for Ultracare Anesthetic Gel
View Indications, Usage & Precautions
Ultracare Anesthetic Gel Product Label
The following document was submitted to the FDA by the labeler of this product The Belport Company, Inc. Dba Gingi-pak. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Active Ingredient
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Do Not Use
.
Otc - Ask Doctor/Pharmacist
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
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
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
Safe Handling Warning
Package Label.Principal Display Panel
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