Label: THERADENT - calcium acetate, potassium nitrate, potassium phosphate, dibasic and sodium fluoride mouthwash 

  • Label RSS
  • NDC Code(s): 52389-118-01, 52389-118-08
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 05/10

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

  • Active ingredients

    Calcium acetate 1x........................................Treatment for sensitive teeth

    Potassium nitrate 6x......................................Treatment for sensitive teeth

    Potassium phosphate 1x................................Treatment for sensitive teeth

    Sodium fluoride 3x.........................................Treatment for sensitive teeth

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  • Uses

    Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

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  • WHEN USING

    When using this product do not use for more than four weeks unless recommended by a dentist or physician.

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  • STOP USE

    Stop use and ask a physician or dentist if problem persists or worsens.  Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

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  • 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 right away.

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  • Directions

    • Read all directions and warnings before use.
    • Use only as directed.
    • Adults:  vigorously swish one teaspoon of rinse between your teeth twice a day for 30 seconds and then spit out.
    • Do not swallow rinse.
    • Theradent is intended for use by normally healthy persons only.
    • Persons under 18 years of age should use only as directed by a dentist or physician.
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  • Other information

    Store at room temperature.  **Contents sealed:  Each bottle of Theradent Sensitive Teeth Rinse has a tamper evident seal under the cap.  Do not use if seal appears broken.  Serious side effects associated with the use of this product may be reported to the phone number listed below.

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  • Inactive ingredients

    Benzoic acid, benzyl alcohol, clove oil, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium saccharin.

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • PATIENT PACKAGE INSERT

    THERADENT Sensitive Teeth Rinse

    Reduces sensitivity to cold, heat, acids, sweets and contact

    Alcohol Free - Fresh Taste

    Homeopathic

    A Word About Medicated THERADENT Sensitive Teeth Rinse

    With your purchase of new THERADENT Sensitive Teeth Rinse you have chosen a totally new and unique way of treating sensitive teeth. What makes THERADENT completely different from other treatments is - THERADENT is a convenient, easy-to-use, non-abrasive liquid oral rinse; not toothpaste. Unlike toothpaste, THERADENT is not rinsed out after use, so it coats teeth with effective medicine for continuing relief throughout the day.

    New THERADENT is a highly effective way to treat sensitivity after and between regular brushing. THERADENT contains a combination of ingredients specially formulated to work together to treat painfully sensitive dental surfaces. Because it's a liquid, THERADENT can deliver relief to even those hard to reach dental crevices not normally accessible with a toothbrush. THERADENT is concentrated, so a little goes a long way in providing lasting relief. When used regularly, you can enjoy the foods and beverages you like without discomfort.

    What Causes Dental/Tooth Sensitivity?

    Millions of people suffer from some form of dental sensitivity, commonly causing their teeth to be painfully sensitive to cold, heat, acids, sweets and contact. Tooth sensitivity can range in intensity from a mild sensation or dull ache...to extreme discomfort. Tooth sensitivity occurs for a number of reasons. Two of the most common are:

    1. Worn tooth enamel, eroded by years of chewing, grinding and/or aggressive brushing, wearing through the enamel surfaces and exposing sensitive nerve paths.
    2. Receding gums, exposing nerves inside teeth that are not protected by tooth enamel below the gum line.

    If you experience dental pain or sensitivity, it is wise to contact your dentist to make the correct diagnosis and advise on an appropriate treatment You may wish to show him/her THERADENT and discuss its use.

    Why Use Theradent?

    1. THERADENT contains 4 active ingredients specifically recognized for their ability to alleviate painful symptoms of dental sensitivity.
    2. THERADENT's unique liquid formula reaches into tight spaces between teeth and below the gum line that aren't always accessible with a toothbrush.
    3. THERADENT's non-abrasive liquid helps minimize irritation of gums and teeth so you can maintain your normal daily dental hygiene/brushing regimen.

    Tips for minimizing painful sensitivity and further erosion of teeth and gums:

    1. Use a soft bristle toothbrush
    2. Use low abrasive toothpaste
    3. Avoid clenching or grinding teeth
    4. Avoid extreme temperatures in food and beverages
    5. Floss regularly and correctly
    6. Visit your dentist regularly and follow his/her advice

    Active ingredients: Calcium acetate 1x, Potassium nitrate 6x, Potassium phosphate 1x, Sodium fluoride 3x.

    Uses: Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

    Warnings

    When using this product do not use for more than four weeks unless recommended by a dentist or physician.

    Stop use and ask a dentist or physician if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Directions:  Read all directions and warnings before use. Use only as directed.  Adults: vigorously swish one teaspoon of rinse between your teeth, thoroughly coating teeth and gums twice a day for 30 seconds and then spit out.  Do not swallow rinse.  THERADENT is intended for use by normally healthy adults only.  Persons under 18 years of age should use only as directed by a dentist or physician.

    Other information:  Store at room temperature. **Contents sealed: Each bottle of THERADENT Sensitive Teeth Rinse has a tamper evident seal under the cap. Do not use if seal appears broken. Serious side effects associated with the use of this product may be reported to the number listed below.

    Inactive ingredients: Benzoic acid, benzyl alcohol, clove oil, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium saccharin.

    Questions?  1-800-792-2582.

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  • INGREDIENTS AND APPEARANCE
    THERADENT 
    calcium acetate, potassium nitrate, potassium phosphate, sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-118
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calcium acetate (Calcium cation) Calcium acetate 1 [hp_X]  in 1 mL
    Potassium nitrate (Potassium cation) Potassium nitrate 6 [hp_X]  in 1 mL
    Potassium phosphate, dibasic (Potassium cation) Potassium phosphate, dibasic 1 [hp_X]  in 1 mL
    Sodium fluoride (Fluoride ion) Sodium fluoride 3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Benzoic acid  
    Benzyl alcohol  
    Clove oil  
    Glycerin  
    Poloxamer 407  
    Water  
    Sodium benzoate  
    Saccharin sodium  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-118-08 1 in 1 CARTON
    1 NDC:52389-118-01 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/17/2006
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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