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Sensitive

Melaleuca, Inc.

Sensitive Fluoride Tooth Polish content of label




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose
Antisensitivity
Anticavity

Uses

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

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

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.

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

Other information

This product contains papain, which may cause allergic reactions

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

Sensitive

Sensitive

Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-205
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.26244 g
POTASSIUM NITRATE NITRATE ION 5.4 g

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
Aloe Vera Leaf
ALPHA-TOCOPHEROL ACETATE
ASCORBYL PALMITATE
CARRAGEENAN
GLYCERIN
GREEN TEA LEAF
HYDRATED SILICA
MYRRH OIL
Papain
POLOXAMER 407
POTASSIUM PYROPHOSPHATE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
SODIUM PYROPHOSPHATE
sorbitol
TEA TREE OIL
titanium dioxide
water
XANTHAN GUM
Xylitol
Zinc Citrate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54473-205-04 108 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2012-01-03


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