RxNorm Names
Review RxNorm Normal Forms
KIDS KARE
(stannous fluoride)
gel
[Zila Therapeutics, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=466fe5be-4c4f-4b91-81a7-93d3fbe09513| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE: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.
OTC - ACTIVE INGREDIENT
Stannous fluoride 0.4% w/w (0.13% w/v fluoride ion)
Contains 0.4% Stannous Fluoride in a Stable, Water Free Gel
INDICATIONS AND USAGE
USES
- 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.
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.
| KIDS KARE
stannous fluoride gel |
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| Labeler - Zila Therapeutics, Inc. (883514127) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Zila Therapeutics, Inc. | 883514127 | MANUFACTURE(59883-643) | |
Revised: 02/2013
Document Id: 57b95ff2-2922-4f96-b39f-0a03e9ef7902
Set id: 466fe5be-4c4f-4b91-81a7-93d3fbe09513
Version: 4
Effective Time: 20130226
Zila Therapeutics, Inc.
