PRO-DEN RX - sodium fluoride gel
Zila Therapeutics, 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.

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Pro-Den Rx

Drug Facts

OTC - ACTIVE INGREDIENT

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

OTC - PURPOSE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRO-DEN RX
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59883-168
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.044 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS (UNII: KH7I04HPUU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/21/2008

Labeler - Zila Therapeutics, Inc. (883514127)

Name	Address	ID/FEI	Business Operations
Establishment
Zila Therapeutics, Inc.		883514127	MANUFACTURE