SENSITIVE TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice

Sensitive by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENSITIVE  TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.26244 g  in 108 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5.4 g  in 108 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CARRAGEENAN (UNII: 5C69YCD2YJ)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MYRRH OIL (UNII: H74221J5J4)
PAPAIN (UNII: A236A06Y32)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SORBITOL (UNII: 506T60A25R)
TEA TREE OIL (UNII: VIF565UC2G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
ZINC CITRATE (UNII: K72I3DEX9B)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-302-04	108 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/03/2012

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		805617610	manufacture(54473-302)