Label: THERADENT - calcium acetate, potassium nitrate, potassium phosphate, dibasic and sodium fluoride mouthwash
- 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.
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- 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 teethClose
Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.Close
- WHEN USING
When using this product do not use for more than four weeks unless recommended by a dentist or physician.Close
- 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.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breastfeeding, ask a health professional before use.Close
- 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.Close
- 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.
- 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.Close
- Inactive ingredients
Benzoic acid, benzyl alcohol, clove oil, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium saccharin.Close
- PATIENT PACKAGE INSERT
THERADENT Sensitive Teeth Rinse
Reduces sensitivity to cold, heat, acids, sweets and contact
Alcohol Free - Fresh Taste
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:
- Worn tooth enamel, eroded by years of chewing, grinding and/or aggressive brushing, wearing through the enamel surfaces and exposing sensitive nerve paths.
- 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?
- THERADENT contains 4 active ingredients specifically recognized for their ability to alleviate painful symptoms of dental sensitivity.
- THERADENT's unique liquid formula reaches into tight spaces between teeth and below the gum line that aren't always accessible with a toothbrush.
- 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:
- Use a soft bristle toothbrush
- Use low abrasive toothpaste
- Avoid clenching or grinding teeth
- Avoid extreme temperatures in food and beverages
- Floss regularly and correctly
- 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.
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.
- INGREDIENTS AND APPEARANCE
calcium acetate, potassium nitrate, potassium phosphate, sodium fluoride mouthwash
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-118 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium acetate (UNII: Y882YXF34X) (Calcium cation - UNII:2M83C4R6ZB) Calcium acetate 1 [hp_X] in 1 mL Potassium nitrate (UNII: RU45X2JN0Z) (Potassium cation - UNII:295O53K152) Potassium nitrate 6 [hp_X] in 1 mL Potassium phosphate, dibasic (UNII: CI71S98N1Z) (Potassium cation - UNII:295O53K152) Potassium phosphate, dibasic 1 [hp_X] in 1 mL Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium fluoride 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Benzoic acid (UNII: 8SKN0B0MIM) Benzyl alcohol (UNII: LKG8494WBH) Clove oil (UNII: 578389D6D0) Glycerin (UNII: PDC6A3C0OX) Poloxamer 407 (UNII: TUF2IVW3M2) Water (UNII: 059QF0KO0R) Sodium benzoate (UNII: OJ245FE5EU) Saccharin sodium (UNII: SB8ZUX40TY) 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)