Label: PRO-DEN RX- sodium fluoride gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 59883-168-16 - Packager: Zila Therapeutics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 16, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- OTC - ACTIVE INGREDIENT
-
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
-
INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride gelProduct 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