PRO-DEN RX- sodium fluoride gel

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Otc medication manufactured, distributed, or labeled by Zila Therapeutics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 Children6 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

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
sodium fluoride gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Zila Therapeutics, Inc. (883514127)

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