BURKHART TOPICAL ANESTHETIC (BENZOCAINE) GEL [BURKHART DENTAL SUPPLY INC]

BURKHART TOPICAL ANESTHETIC (BENZOCAINE) GEL [BURKHART DENTAL SUPPLY INC]
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NDC 43498-312-30
Set ID 2282ea74-94c1-40be-a77f-290763a76250
Category HUMAN OTC DRUG LABEL
Packager Burkhart Dental Supply Inc
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredients

    Benzocaine 200mg (in each g)

  • Purpose

    Oral Anesthetic

  • Use

    For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

  • Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
    Do not use

    • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
    • for teething
    • in children under 2 years of age

    When using this product Avoid contact with eyes. If contact occurs, flush with water.

    Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
    If pregnant or breast feeding, ask a physician before use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children.

  • Directions

    • Apply only amount needed to the oral mucosa to prevent or relieve pain.
    • children under 2 years of age: do not use
  • Other Information

    Store at 59°-86°F (15°-30°C). Protect from freezing.

  • Inactive Ingredients

    flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

  • Questions of comments?

    1.800.562.8176

    www.burkhartdental.com

  • PRINCIPAL DISPLAY PANEL

    Topical_Burkhart.jpg

  • INGREDIENTS AND APPEARANCE
    BURKHART TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43498-312
    Route of AdministrationDENTAL
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43498-312-3030 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/01/2015
    Labeler - Burkhart Dental Supply Inc (027532357)

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