KIDS KARE - stannous fluoride gel
Zila Therapeutics, Inc.
Disclaimer: 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.
----------
DRUG FACTS
ACTIVE INGREDIENTS
Stannous fluoride 0.4% w/w (0.13% w/v fluoride ion)
Contains 0.4% Stannous Fluoride in a Stable, Water Free Gel
PURPOSE
Anticavity
USES
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 INGREDIENTS:
Natural flavor, glycerin and hydroxyethyl cellulose
Made for and Distributed in US by: Zila Therapeutics, Inc.,
P.O. Box 3889, Batesville, AR 72503
1-800-228-5595
KIDS KARE
kids kare gel |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Labeler - Zila Therapeutics, Inc. (883514127) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Zila Therapeutics, Inc. | 883514127 | MANUFACTURE |