EXCEED TOTAL CARE SENSITIVE SPEARMINT TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice

Exceed Total Care Sensitive by

Drug Labeling and Warnings

Exceed Total Care Sensitive by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Uses

• aids in the prevention of dental cavaties
• helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS

Warnings

• Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
• Sensitivt teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age or older: apply at least a 1-inch strup of the tooth polish onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Be sure to brush all sensitive areas of the teeth.
• children under 12 years of age: consult a dentist or doctor

INACTIVE INGREDIENT

Inactive Ingredients water, hydrated silica, glycerin, sorbitol, flavor, xanthan gum, stevia leaf extract, propanediol, poloxamer 407, zinc citrate, tetrasocium pyrophosphate, titanium dioxide, lauramidopropyl betaine, benzyl alcohol, sodium hydroxide, melaleuca alternifolia (tea tree) leaf oil.

ACTIVE INGREDIENT

Active Ingredient Purpose

Sodium fluoride (0.243%w/w)........................Anticavity

Potassium nitrate (5.0%w/w)...................Antisensitivity

PURPOSE

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXCEED TOTAL CARE SENSITIVE  SPEARMINT TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-337
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	0.2272 g  in 93.5 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	4.675 g  in 93.5 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPANEDIOL (UNII: 5965N8W85T)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
REBAUDIOSIDE A (UNII: B3FUD0528F)
SORBITOL (UNII: 506T60A25R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-337-04	93.5 g in 1 TUBE; Type 0: Not a Combination Product	01/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/08/2022

Labeler - Melaleuca, Inc (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc		805617610	manufacture(54473-337)