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Whitening

Melaleuca, Inc.

Fluoride Tooth Polish Cool Mint Content of Label




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient
Sodium Fluoride (0.243%)

Purpose

Purpose
Anticavity

Uses

Use aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Warning: This product contains propolis, which can cause allergic reactions.

Directions

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
  • instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 2 years of age: consult a dentist or physician

Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol

Whitening

Whitening

Sodium Fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-188
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.26244 g

Inactive Ingredients

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54473-188-04 108 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-04-01


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