Label: ULTRACARE ANESTHETIC GEL- benzocaine gel

  • NDC Code(s): 10129-072-01
  • Packager: The Belport Company, Inc. DBA Gingi-Pak
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 20, 2024

If you are a consumer or patient please visit this version.

  • 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.

  • ADVERSE REACTIONS

    alert

  • ACTIVE INGREDIENT

    Benzocaine 20% w/v

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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 yearsdnu .

  • ASK DOCTOR/PHARMACIST

    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

    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

    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

  • SAFE HANDLING WARNING

    storage

  • Oral Anesthetic

  • PRINCIPAL DISPLAY PANEL

    factsfactslable

  • INGREDIENTS AND APPEARANCE
    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)