TOPICAL 60 SEC SODIUM FLUORIDE  STRAWBERRY- 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.

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Patterson® 60-Second Foam Fluoride Strawberry

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

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 Strawberry 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.
0531150LA, R2-012018

PRINCIPAL DISPLAY PANEL - 125 g Canister Label

PATTERSON®
DENTAL

NDC# 50227-0501-6

Patterson® 60-Second
Foam Fluoride

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

Strawberry

NET WT. 4.4 OZ (125 g)

Rx Only

Reorder Number
088-6119

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
TOPICAL 60 SEC SODIUM FLUORIDE   STRAWBERRY
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50227-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride123 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-0501-61 in 1 BOX04/01/1997
1125 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/1997
Labeler - Patterson Dental Supply Inc (171843584)

Revised: 12/2018
Document Id: 54dde303-7e67-489b-b236-4457f8df4725
Set id: 761d81ef-e4e0-451a-959f-6617c7818e00
Version: 2
Effective Time: 20181220
 
Patterson Dental Supply Inc