Label: TOPICAL 60 SEC SODIUM FLUORIDE BUBBLE GUM- sodium fluoride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 50227-0521-6 - 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 December 20, 2018
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- INDICATIONS AND USAGE
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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.
- CONTRAINDICATIONS
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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.
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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
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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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 125 g Canister Label
PATTERSON®
DENTALNDC# 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
088-6135Manufactured 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. -
INGREDIENTS AND APPEARANCE
TOPICAL 60 SEC SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-0521 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 (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 BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-0521-6 1 in 1 BOX 04/01/1997 1 125 g in 1 CANISTER; Type 0: Not a Combination Product 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)