Label: SENSICAINE TM EXTRA TOPICAL ANESTHETIC- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 11, 2018

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

  • Active ingridients (in each gram)

    Benzocaine 200 mg

  • 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 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 benzocaine or other "caine" anesthetics.

    Sore throat warning:If sore throat is severe,persists for more than 2 days,is accompanied or followed by fever, headache, rash, swelling, nausea,or vomiting, consult a doctor promptly.If sore mouth symptoms do not improve in 7 days, or if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.

  • Do not use

    • for teething
    • in children under 2 years of age
  • WHEN USING

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, consult a doctor before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    • adults and children 2 years of age and older: 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 - 86ºF (15 - 30ºC).
    • Protect from freezing.
  • Inactive ingredients

    flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.

  • Questions or comments?

    800-621-2178

    www.safcodental.com

  • PRINCIPAL DISPLAY PANEL - Jar Label

    SAFCO
    SensiCaineTM Extra

    Topical Anesthetic Gel

    Contains 20% Benzocaine

    Cherry Flavor

    For Professional Use Only

    1 oz. (34 g)

    PRINCIPAL DISPLAY PANEL - 29.6 g Jar Label
    PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label 2
  • INGREDIENTS AND APPEARANCE
    SENSICAINE TM EXTRA  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0212
    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)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67239-0212-129 g in 1 JAR; Type 0: Not a Combination Product04/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35604/30/2017
    Labeler - Safco Dental Supply Co. (020417380)
    Registrant - Safco Dental Supply Co. (020417380)