Pro-den rx gel
Spl unclassified section
Otc - active ingredient
Active IngredientsStannous fluoride 0.4% w/w (0.13% w/v fluoride ion)
Otc - purpose
Indications and usage
- Aids in prevention of dental caries (cavities).
- The combined daily use of a fluoride preventive treatment gel and a fluoride toothpaste can help reduce the incidence of dental cavities.
Otc - keep out of reach of children
PLEASE KEEP OUT OF REACH OF CHILDREN.
- If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- Use only under guidance or supervision of a dentist.
Dosage and administration
|Adults and Children 6 Years and Older||This is a fluoride preventive treatment gel, not a toothpaste. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.|
|Children 6 to 12||Instruct and supervise brushing and rinsing (to minimize swallowing) until good brushing habits are established.|
|Children Under 6||Ask a dentist or doctor.|
Other Information:This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dental professional.
Glycerin and hydroxyethyl cellulose
Rev. 1 1008
Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503
Ingredients and appearance - Product information
Pro-den rx gel- Stannous fluoride
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 59883-648|
|Route of Administration||Oral|
|Stannous fluoride ( UNII: 3FTR44B32Q)( Fluoride ion - UNII: Q80VPU408O )||1.3 mgin 1 mL|
|Hydroxyethyl cellulose (140 mpa.s at 5%)||( UNII: 8136Y38GY5)|
|Glycerin||( UNII: PDC6A3C0OX)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|unapproved drug other||USA|
Labeler - Den-mat Holdings, Llc( 809857704)
|Den-mat Holdings, Llc||809857704||MANUFACTURE( 59883-648)|