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Denti-Care Denti-Freeze (AR Medicom Inc)

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GEL 28.4 g in 1 JAR (64778-0393-1) Label Information

Complete Denti-Care Denti-Freeze Information

  • DESCRIPTION

    Medicom

    Denti-Care

    Denti-Freeze

    Topical Anesthetic Gel

    Bubblegum

    1 oz / 28.4 g

    NDC 64778-0393-1

    DIN 02318148
  • DOSAGE & ADMINISTRATION

    For rapid and long lasting topical anesthesia.

    Directions: Apply 0.2 mL of gel to the desired area using a cotton swab.

    Active ingredients: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w




  • WARNINGS AND PRECAUTIONS

    Warnings: KEEP OUT OF REACH OF CHILDREN.

    Store at room temperature.

    Do not expose to excessive heat (over 40 degrees C or 104 degrees F)

  • SPL UNCLASSIFIED SECTION

    Made in USA for: A.R. Medicom Inc. Montreal, Canada H8T 3J8

    Questions: 1-800-361-2862 or www.medicom.com

    UPC 686864010982

    Item 10039-BG

    No. 112437

    Rev.2

  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-FREEZE  TOPICAL ANESTHETIC BUBBLEGUM
    benzocaine, tetracaine hydrochloride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0393
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 0.18 g  in 1 g
    tetracaine hydrochloride (UNII: 5NF5D4OPCI) (tetracaine - UNII:0619F35CGV) tetracaine 0.02 g  in 1 g
    Product Characteristics
    Color pink (fuschia) Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0393-1 28.4 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/01/2000
    Labeler - AR Medicom Inc (247876295)