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  5. Label Information: Sensitive Tooth Polish

FDA Label for Sensitive Tooth Polish

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. PRECAUTIONS
    9. INACTIVE INGREDIENT

Sensitive Tooth Polish Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients
Potassium nitrate (5.0% w/w)
Sodium fluoride (0.243% w/w)


Otc - Purpose



Purpose
Antisensitivity
Anticavity


Indications & Usage



Uses

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • aids in the prevention of cavities

Warnings



Warnings
When using this product do not use longer than four weeks unless recommended by a dentist


Otc - Stop Use



Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions

  • adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

Precautions



Other information

This product contains papain, which may cause allergic reactions


Inactive Ingredient



Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate


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