TOPICAL 60 SEC SODIUM FLUORIDE ORANGE CREAM- sodium fluoride aerosol, foam

Topical 60 Sec Sodium Fluoride by

Drug Labeling and Warnings

Topical 60 Sec Sodium Fluoride by is a Prescription medication manufactured, distributed, or labeled by Patterson Dental Supply Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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, Artificial Orange Cream Flavor, Cetyl Alcohol, Sodium Methyl Cocoyl Taurate, Sodium Phosphate Monobasic Monohydrate, 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.]

SPL UNCLASSIFIED SECTION

Made in U.S.A.
0531154LA, R2-012018

PRINCIPAL DISPLAY PANEL - 125 g Canister Label

PATTERSON®
DENTAL

NDC# 50227-0541-6

Patterson® 60-Second
Foam Fluoride

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

Orange Cream

NET WT. 4.4 OZ (125 g)

Rx Only

Reorder Number
088-6150

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.

INGREDIENTS AND APPEARANCE

TOPICAL 60 SEC SODIUM FLUORIDE   ORANGE CREAM
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50227-0541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	123 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Cetyl Phosphate (UNII: VT07D6X67O)
Cetyl Alcohol (UNII: 936JST6JCN)
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN)
Apaflurane (UNII: R40P36GDK6)
Benzaldehyde (UNII: TA269SD04T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50227-0541-6	1 in 1 BOX	04/01/1997
1		125 g in 1 CANISTER; Type 0: Not a Combination Product

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)