Indications And Usage
For topical application to aid in the prevention of dental caries.
Treatment frequency should not exceed 4 treatments per year.
Topical 60 Sec Sodium Fluoride
FDA Label NDC 50227-0521
11 label sections · Submitted to the FDA by Patterson Dental Supply Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental Supply Inc for the product Topical 60 Sec Sodium Fluoride (NDC 50227-0521). 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 indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, overdosage, adverse reactions, ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Shake can thoroughly for at least 10 seconds before each use.
Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Dry tooth surface and insert tray(s) into mouth. Have patient bite down for 1 minute or up to 4 minutes.
Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for 30 minutes.
Dosage Forms And Strengths
This topical foam contains 1.23% fluoride ion.
Contraindications
Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.
Warnings And Precautions
- Do not swallow. Harmful if swallowed.
- Keep out of reach of children.
- Contents under pressure. Do not puncture or incinerate can.
- This product is not intended for home or unsupervised consumer use.
- Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.
Overdosage
If treatment dose is swallowed (less than 100 mg F), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.
Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.
Adverse Reactions
Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness.
Ingredients
Purified Water, Heptafluoropropane (Propellant), Denatured Ethyl Alcohol (Benzaldehyde), Sodium Fluoride, Crodafos 03A-LQ, Polyethylene Glycol 400, Crodafos MCASA-PA, Cetyl Alcohol, Sodium Methyl Cocoyl Taurate, Sodium Phosphate Monobasic Monohydrate, Artificial Bubble Gum Flavor, Sodium Saccharin, Sodium Benzoate
Storage
Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]
Other
Made in U.S.A.
0531152LA, R2-012018
Principal Display Panel - 125 G Canister Label
PATTERSON®
DENTAL
NDC# 50227-0521-6
Patterson® 60-Second
Foam Fluoride
(APF*) Topical Fluoride Solution
*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)
Bubble Gum
NET WT. 4.4 OZ (125 g)
Rx Only
Reorder Number
088-6135
Manufactured for:
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
!
Danger: Extremely flammable aerosol.
Contains gas under pressure; may explode
if heated.
May cause an allergic skin reaction.
Causes serious eye damage.
Principal Display Panel (125 g Canister Label)
* Please review the disclaimer below.
