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

  • NDC Code(s): 50227-0511-6
  • Packager: Patterson Dental Supply Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/12

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, spearmint 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

    0531151LA, R1-022912

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  • PRINCIPAL DISPLAY PANEL - 125 g Canister Label

    PATTERSON
    DENTAL

    NDC# 50227-0511-6

    60-Second
    Foam Fluoride

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

    MINT

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

    Reorder Number
    088-6127

    NET WT. 4.4 OZ. (125g)

    Principal Display Panel - 125 g Canister Label
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  • INGREDIENTS AND APPEARANCE
    TOPICAL 60 SEC SODIUM FLUORIDE   MINT
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50227-0511
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Sodium Fluoride 123 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50227-0511-6 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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