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.

----------

60-Second Foam Fluoride Strawberry

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, strawberry flavor.

Warning

Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate.

Store between temperatures 55-80°F. Keep from freezing.

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

0531150LA, R1-022912

PRINCIPAL DISPLAY PANEL - 125g Canister Label

PATTERSON
DENTAL

NDC# 50227-0501-6

60-Second
Foam Fluoride

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

STRAWBERRY

Caution: For professional use only.
Store at room temperature.
Shake well before each use.

Reorder Number
088-6119

NET WT. 4.4 OZ. (125g)

PRINCIPAL DISPLAY PANEL - 125g Canister Label
TOPICAL 60 SEC SODIUM FLUORIDE   STRAWBERRY
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-0501
Route of Administration TOPICAL DEA Schedule     
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 DIHYDRATE (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 STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50227-0501-6 1 in 1 BOX
1 125 g in 1 CANISTER
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: 5/2012
Document Id: b67d45f7-77f8-4a06-aa4d-4db91a9a7d92
Set id: 761d81ef-e4e0-451a-959f-6617c7818e00
Version: 1
Effective Time: 20120501
 
Patterson Dental Supply Inc