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Pro-Den Rx

FULL PRESCRIBING INFORMATION

Drug Facts

Sodium Fluoride 0.044% w/w (0.02% w/v fluoride ion)

Anticavity

Approved Uses

Aids in prevention of dental caries (cavities).
The combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Warnings

Please keep out of reach of children.
If more than used for rinsing is accidentally swallowed get medical help or contact a Poison Control Center right away. Use only under guidance or supervision of a dentist or doctor.

Directions: This is a fluoride treatment rinse, not a mouthwash. Read directions carefully before using.

Adults and Children 6 yrs and older	Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
Children 6 to 12	Instruct and supervise in good rinsing (to minimize swallowing).
Children Under 6	Consult a dentist or doctor.

Inactive Ingredients:

Distilled water, monosodium phosphate, sodium benzoate, sodium saccharin, artificial color, artificial flavor.

Made for and Distributed in US by:
Zila Therapeutics, Inc.,

P.O. Box 3889, Batesville, AR 72503

1-800-228-5595

Sodium Fluoride GEL

Product Information
Product Type	Human otc drug label	Item Code (Source)	NDC:59883-168
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE FLUORIDE ION		0.044 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE
saccharin sodium
water
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC:59883-168-16	473 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
part	part352	2008-11-21

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!