WHITENING TOOTH POLISH- sodium fluoride paste

Whitening by

Drug Labeling and Warnings

Whitening by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc., Melaleuca, Inc._Knoxville. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Sodium Fluoride (0.243%)

PURPOSE

Purpose
Anticavity

INDICATIONS & USAGE

Use aids in the prevention of dental cavities

WARNINGS

Warnings

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITENING  TOOTH POLISH
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.26244 g  in 108 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MYRRH OIL (UNII: H74221J5J4)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TEA TREE OIL (UNII: VIF565UC2G)
PAPAIN (UNII: A236A06Y32)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2010

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc._Knoxville		805617610	manufacture