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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 20, 2018

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

  • 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

    • Do not swallow. Harmful if swallowed.
    • Keep out of reach of children.
    • Contents under pressure. Do not puncture or incinerate can.
    • This product is not intended for home or unsupervised consumer use.
    • Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.
  • 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 Bubble Gum 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.]

  • SPL UNCLASSIFIED SECTION

    Made in U.S.A.
    0531152LA, R2-012018

  • PRINCIPAL DISPLAY PANEL - 125 g Canister Label

    PATTERSON®
    DENTAL

    NDC# 50227-0521-6

    Patterson® 60-Second
    Foam Fluoride

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

    Bubble Gum

    NET WT. 4.4 OZ (125 g)

    Rx Only

    Reorder Number
    088-6135

    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.
    May cause an allergic skin reaction.
    Causes serious eye damage.

    PRINCIPAL DISPLAY PANEL - 125 g Canister Label
  • INGREDIENTS AND APPEARANCE
    TOPICAL 60 SEC SODIUM FLUORIDE   BUBBLE GUM
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50227-0521
    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
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50227-0521-61 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)