Label: TOPICAL ANESTHETIC RASPBERRY- 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 December 17, 2017

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  • ACTIVE INGREDIENT

    INGREDIENTS

    Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40, FD&C Blue #1 and D&C Red #28.

  • USUAL DOSAGE

    For oral mucosal use only as directed by a dentist.

  • WARNING

    Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

  • HOW SUPPLIED

    Store at controlled room temperature 59-86°F (15-30°C).

  • INDICATIONS & USAGE

    CAUTION

    Federal law prohibits dispensing without a prescription.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Safco Dental Supply Co.
    Buffalo Grove, IL 60089
    800-621-2178
    www.safcodental.com

  • PRINCIPAL DISPLAY PANEL - Jar Label

    SAFCO
    SensiCaine

    Topical Anesthetic Gel

    Raspberry Flavor

    Contains 20% Benzocaine

    For Professional Use Only

    1 oz. (34 g)

    PRINCIPAL DISPLAY PANEL - Jar Label
  • INGREDIENTS AND APPEARANCE
    TOPICAL ANESTHETIC   RASPBERRY
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0208
    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 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Water (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67239-0208-134 g in 1 JAR; Type 0: Not a Combination Product08/06/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35608/06/2012
    Labeler - Safco Dental Supply Co. (020417380)
    Registrant - Safco Dental Supply Co. (020417380)
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