VISTACAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [INTER-MED, INC.]

VISTACAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [INTER-MED, INC.]
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NDC 64522-004-30
Set ID 632c9ed0-3b9b-4fa8-817e-c4ac7e21ad59
Category HUMAN OTC DRUG LABEL
Packager Inter-Med, INC.
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredients (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

    • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
    • ​Do Not Use​ for more than 7 days unless directed by a dentist or doctor. 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 dentist or doctor promptly.
    • ​When using this product​ avoid contact with eyes. If contact occurs, flush with water.
    • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
    • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
    • ​If pregnant or breast feeding, ​ask a health professional 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.

  • ​Other Information

    Store at 59º -86°F (15 - 30°C).

    Protect from freezing.

  • ​Inactive ingredients

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

  • Questions or comments?

    1-262-636-9755

  • PRINCIPAL DISPLAY PANEL

    LB.Vista Topical Wrap_R7.jpg

  • INGREDIENTS AND APPEARANCE
    VISTACAINE TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64522-004
    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)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64522-004-3030 g in 1 JAR; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/2018
    Labeler - Inter-Med, INC. (036623932)

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