FDA Label for Topical 60 Sec Sodium Fluoride Bubble Gum
View Indications, Usage & Precautions
Topical 60 Sec Sodium Fluoride Bubble Gum 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
For topical application to aid in the protection against dental caries.
Medical Ingredient
1.23% Fluoride ion from sodium fluoride.
Non-Medical Ingredients
Sodium saccharin, sodium benzoate, sodium methyl cocoyl taurate, polyethylene glycol 400, cetyl alcohol, Cetyl phosphate (and) Stearic Acid, Oleth-3 Phosphate, heptafluoropropane HFC 227, SDA 38B (benzaldehyde) 200 proof, sodium phosphate monobasic monohydrate, bubble gum flavor.
Warning
Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate.
Storage And Handling
Store between temperatures 55-80°F. Keep from freezing.
Other
Federal (U.S.A.) Law prohibits dispensing without prescription.
Manufactured for:
PATTERSON DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
MADE IN U.S.A.
Patent Pending
0531152LA, R1-021712
Principal Display Panel - 125G Canister Label
PATTERSON
DENTAL
NDC# 50227-0521-6
60-Second
Foam Fluoride
APF* Topical Fluoride Solution
*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)
BUBBLE GUM
Caution: For professional use only.
Store at room temperature.
Shake well before each use.
Reorder Number
088-6135
NET WT. 4.4 OZ. (125g)
* Please review the disclaimer below.