Label: ORABASE BENZOCAINE  PURPLE ICE- benzocaine paste, dentifrice 

  • NDC Code(s): 0126-0082-04
  • Packager: Colgate Oral Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Benzocaine 20%

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  • Purpose

    Oral Pain Reliever

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  • Use

    for temporary relief of pain associated with canker sores, due to minor irritation or injury of the mouth and gums, or due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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  • Warnings

    Do not use

    • for more than 7 days unless directed by a dentist or physician
    • if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

    When using this product

    • do not exceed recommended dosage
    • avoid contact with eyes
    • localized allergic reactions may occur after prolonged or repeated use

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens

    Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • adults and children 2 years and older: gently dab paste on the site of irritation with a cotton swab or fingertip
    • allow to remain in place at least 1 minute and then spit out
    • use up to 4 times daily or as directed by a dentist or physician
    • children under 12 years of age should be supervised in the use of the product
    • children under 2 years of age: consult a dentist or physician
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  • Other information

    store at controlled room temperature, 68-77°F (20-25°C)

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  • Inactive ingredients

    mineral oil, cellulose gum, pectin, xanthan gum, polyethylene, flavor

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  • Questions or comments?

    call toll-free 1-800-962-2345

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  • PRINCIPAL DISPLAY PANEL - 11.9 g Tube Carton

    Colgate®

    Orabase®
    20% Benzocaine

    ALCOHOL FREE

    Maximum Strength
    Oral Pain Reliever

    NET WT 0.42 OZ (11.9 g)

    PRINCIPAL DISPLAY PANEL - 11.9 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    ORABASE BENZOCAINE   PURPLE ICE
    benzocaine paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0126-0082
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 19.8 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mineral Oil  
    Xanthan Gum  
    Carboxymethylcellulose Sodium  
    Pectin  
    High Density Polyethylene  
    Isoxaflutole  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE, MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0126-0082-04 12 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 08/01/2012
    Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)
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