FDA Label for Take Home Fluoride Cool Mint
View Indications, Usage & Precautions
Take Home Fluoride Cool Mint Product Label
The following document was submitted to the FDA by the labeler of this product Patterson Dental Supply Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications
Helps prevent dental caries and hypersensitivity.
Active Ingredient
Sodium Fluoride 1.1% (0.5% Fluoride Ion)
Other Ingredients
Purified water, glycerin, Xylitol and other sweeteners. Contains FD&C Blue #1
Directions
Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.
- Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
- Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.
Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.
Warnings
DO NOT SWALLOW. Supervision is required while children are using this product in order to avoid ingestion. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF INFANTS & CHILDREN.
Precautions
For Professional Use only. Federal (USA) law prohibits dispensing without a prescription. Store at controlled room temperature 68° -77° F (20° - 25°C).
Other
NDC# 5022710062
Manufactured in the USA
Questions? Call your dentist for more information.
Distributed by
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
St. Paul, MN 55120
Reorder# 088-6093 12/Case
Principal Display Panel - 56 Gm Tube Label
PATTERSON BRAND
Take Home Fluoride
1.1% Neutral Sodium Fluoride Gel
Cool
Mint
Contains
Xylitol
Natural Sweetener
Net Wt. 2 Oz (56gm)
* Please review the disclaimer below.