Active Ingredient
Stannous Fluoride 0.4% (0.12% w/v fluoride ion)
Kids Kare Gel
FDA Label NDC 59883-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc. for the product Kids Kare (NDC 59883-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities.
Warnings
This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Otc - When Using
When using this product it may produce surface staining of the teeth, Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Otc - Keep Out Of Reach Of Children
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.
Directions
- Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
- Apply the get to your teeth and brush thoroghly. 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.
- Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
Other Information
Do not use if the foil seal under the cap is torn, cut or missing.
Inactive Ingredient
Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine
Questions Or Comments?
1-800-752-2564
Principal Display Panel
kids kare™
Preventative Treatment
0.4% Stannous Fluoride
Brush-On Gel
BERRY FLAVOR
IMPORTANT:
Read directions carefully
Net Wt. 4.3 oz. (121.9 g)
* Please review the disclaimer below.
