[Zila Therapeutics, Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Stannous fluoride 0.4% w/w (0.13% w/v fluoride ion)
Contains 0.4% Stannous Fluoride in a Stable, Water Free Gel
- 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.
- 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.
|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.|
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.
Natural flavor, glycerin and hydroxyethyl cellulose
Made for and Distributed in US by: Zila Therapeutics, Inc.,
P.O. Box 3889, Batesville, AR 72503
stannous fluoride gel
|Labeler - Zila Therapeutics, Inc. (883514127)|
|Zila Therapeutics, Inc.||883514127||MANUFACTURE(59883-643)|