Western Family Tartar Control: Package Insert and Label Information

WESTERN FAMILY TARTAR CONTROL — sodium fluoride paste, dentifrice
Western Family Foods, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

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

Helps protect against cavities.

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.

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, Hydrated Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin, FDC Blue 1

Principal Display Panel

WESTERN FAMILY TARTAR CONTROL sodium fluoride paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-163 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 2.43 mg in 1 g

Inactive Ingredients Ingredient Name Strength SORBITOL SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 300 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE TITANIUM DIOXIDE SODIUM PYROPHOSPHATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM FD&C BLUE NO. 1

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55312-163-07 232.4 g in 1 TUBE None

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)

Revised: 03/2011 Western Family Foods, Inc