Pro-den rx gel

Spl unclassified section

Drug Facts

Otc - active ingredient

Active IngredientsStannous fluoride 0.4% w/w (0.13% w/v fluoride ion)

Otc - purpose

Anticavity

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.

Warnings

  • 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

Directions:

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.

Inactive ingredient

Glycerin and hydroxyethyl cellulose

Rev. 1 1008

Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503
1-800-228-5595

Ingredients and appearance - Product information

Pro-den rx gel- Stannous fluoride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 59883-648
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Stannous fluoride ( UNII: 3FTR44B32Q)( Fluoride ion - UNII: Q80VPU408O ) 1.3 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Hydroxyethyl cellulose (140 mpa.s at 5%) ( UNII: 8136Y38GY5)
Glycerin ( UNII: PDC6A3C0OX)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Den-mat Holdings, Llc( 809857704)

Establishment

Name ID/FEI Business Operations
Den-mat Holdings, Llc 809857704 MANUFACTURE( 59883-648)

Package label.principal display panel