Pro-Den Rx description, usages, side effects, indications, overdosage, supplying and lots more!

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Pro-Den Rx

Zila Therapeutics, Inc.

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

Pro-Den Rx

Pro-Den Rx

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


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