WESTERN FAMILY SENSITIVE WHITENING FLUORIDE- potassium nitrate and sodium fluoride paste, dentifrice

Western Family Sensitive Whitening Fluoride by

Drug Labeling and Warnings

Western Family Sensitive Whitening Fluoride by is a Otc medication manufactured, distributed, or labeled by Western Family Food, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Potassium Nitrate 5%..................Antihypersensitivity

Sodium Fluoride 0.243% (0.15% w/v fluoride ion).......Anticavity Toothpaste

PURPOSE

KEEP OUT OF REACH OF CHILDREN

USE

• builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
• aids in the prevention of dental cavities
  

WARNINGS

When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor.  Stop and ask a dentist if problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist.  Keep out of reach of children.

Directions

Adults and children          Brush teeth for at least one minute, preferably after
12 years and older           each meal, or at least twice a day, or as directed by your dentist. 
                                          Be sure to brush sensitive areas.

Children under                 Consult a dentist or doctor.
12 years of age

Other information            Store in a cool, dry place.

Inactive Ingredients

Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose gum, Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin

Principal Display Panel

INGREDIENTS AND APPEARANCE

WESTERN FAMILY SENSITIVE WHITENING FLUORIDE 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-158
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM NITRATE	5 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-158-09	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/02/2007

Labeler - Western Family Food, Inc. (192166072)