Your browser does not support JavaScript! TOPICAL 60 SEC SODIUM FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]
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TOPICAL 60 SEC SODIUM FLUORIDE ORANGE CREAM (sodium fluoride) aerosol, foam
[Patterson Dental Supply Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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, orange 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

0531154LA, R1-022912

PRINCIPAL DISPLAY PANEL - 125g Canister Label

PATTERSON
DENTAL

NDC# 50227-0541-6

60-Second
Foam Fluoride

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

ORANGE CREAM

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

Reorder Number
088-6150

NET WT. 4.4 OZ. (125g)

Principal Display Panel - 125g Canister Label
TOPICAL 60 SEC SODIUM FLUORIDE   ORANGE CREAM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-0541
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride123 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Saccharin Sodium Dihydrate 
Sodium Benzoate 
Sodium Methyl Cocoyl Taurate 
Polyethylene Glycol 400 
Cetyl Phosphate 
Cetyl Alcohol 
Oleth-3 Phosphate 
Sodium Phosphate, Monobasic, Monohydrate 
Apaflurane 
Benzaldehyde 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50227-0541-61 in 1 BOX
1125 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/1997
Labeler - Patterson Dental Supply Inc (171843584)

Revised: 04/2012
Document Id: 30034c1e-56bf-4c01-b8ed-45ecfad739df
Set id: d4a0d96b-d71c-4c54-ab8b-65e4c4615175
Version: 1
Effective Time: 20120426
 
Patterson Dental Supply Inc

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