Label: TOPICAL 60 SEC SODIUM FLUORIDE STRAWBERRY- sodium fluoride aerosol, foam

  • NDC Code(s): 50227-0501-6
  • Packager: Patterson Dental Supply Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 1, 2012

If you are a consumer or patient please visit this version.

  • Indications

    For topical application to aid in the protection against dental caries.

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  • Medical Ingredient

    1.23% Fluoride ion from sodium fluoride.

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  • 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.

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  • Warning

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

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  • STORAGE AND HANDLING

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

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  • SPL UNCLASSIFIED SECTION

    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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    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
    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)
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