WESTERN FAMILY WHITENING- sodium fluoride paste, dentifrice

Western Family Whitening by

Drug Labeling and Warnings

Western Family Whitening 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

INDICATIONS & USAGE

Helps protect against cavities.

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.

DOSAGE & ADMINISTRATION

Adults and children            Brush teeth throughly, 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, Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Sodium Saccharine

Principal Display Panel

INGREDIENTS AND APPEARANCE

WESTERN FAMILY WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-162
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-162-05	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)