ULTRACARE ANESTHETIC GEL- benzocaine gel 
The Belport Company, Inc. DBA Gingi-Pak

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UltraCare, Bubblegum

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.

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.

alert

Benzocaine 20% w/v

keep out of reach of children Keep out of reach of children

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 yearsdnu .

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.

Dose admin

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

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

storage

Oral Anesthetic

factsfactslable

ULTRACARE ANESTHETIC GEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-072
Route of AdministrationDENTAL, PERIODONTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10129-072-0130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/20/2024
Labeler - The Belport Company, Inc. DBA Gingi-Pak (008480121)

Revised: 3/2024
Document Id: 142062ca-6f90-78d2-e063-6294a90a19d8
Set id: 142062ca-6f8f-78d2-e063-6294a90a19d8
Version: 1
Effective Time: 20240320
 
The Belport Company, Inc. DBA Gingi-Pak