Topical 60 Sec Sodium Fluoride Grape

TOPICAL 60 SEC SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam
Patterson Dental Supply Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

INDICATIONS AND USAGE

For topical application to aid in the prevention of dental caries.

Treatment frequency should not exceed 4 treatments per year.

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.

Topical 60 Sec Sodium Fluoride Grape 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 Grape 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.]

Made in U.S.A.
0531153LA, R2-012018

PRINCIPAL DISPLAY PANEL — 125 g Canister Label

PATTERSON®
DENTAL

NDC# 50227-0531-6

Patterson® 60-Second
Foam Fluoride

(APF*) Topical Fluoride Solution
*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)

Grape

NET WT. 4.4 OZ (125 g)

Rx Only

Reorder Number
088-6143

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.
Causes serious eye damage.

PRINCIPAL DISPLAY PANEL -- 125 g Canister Label
(click image for full-size original)
TOPICAL 60 SEC SODIUM FLUORIDE GRAPE
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-0531
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride 123 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Sodium Benzoate
SODIUM METHYL COCOYL TAURATE
Polyethylene Glycol 400
CETYL PHOSPHATE
Cetyl Alcohol
OLETH-3 PHOSPHATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
APAFLURANE
Benzaldehyde
Product Characteristics
Color WHITE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50227-0531-6 1 CANISTER in 1 BOX contains a CANISTER
1 125 g in 1 CANISTER This package is contained within the BOX (50227-0531-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/01/1997
Labeler — Patterson Dental Supply Inc (171843584)

Revised: 12/2018 Patterson Dental Supply Inc

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