WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY- sodium fluoride paste, dentifrice

Western Family Whitening Plus Minty Fresh Mouthwash Anticavity by

Drug Labeling and Warnings

Western Family Whitening Plus Minty Fresh Mouthwash Anticavity by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

PURPOSE

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children          Brush teeth thoroughly, preferably after
2 years and older             each meal, or at least twice a day, or as
                                          directed by your dentist. Do not swallow.

Children under                  To minimize swallowing, use a pea-sized
6 years of age                  amount and supervise brushing until
                                          good habits are established.

Children under 2 years     Ask a dentist or physician.     

Inactive Ingredients:

Sorbitol, Water, Hydrated Silica, PEG-6, Sodium Lauryl Sulphate, Alcohol (1.14%), Flavor, Xanthan Gum, Carbomer, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Triclosan, Blue 1, Yellow 4.

Principal Display Panel

WARNINGS

As with all fluoride toothpastes, keep out of reach of children under 6 years of age.  If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

USE

Helps protect against cavities.

INGREDIENTS AND APPEARANCE

WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-182
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALCOHOL (UNII: 3K9958V90M)	1.14 mg  in 1 g
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRICLOSAN (UNII: 4NM5039Y5X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-182-05	181.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/24/2008

Labeler - Western Family Foods, Inc (192166072)