Label: TAKE HOME FLUORIDE COOL MINT- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 50227-1006-2 - 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 April 26, 2012
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- INDICATIONS
- ACTIVE INGREDIENT
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DIRECTIONS
Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.
- Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
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Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.
Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.
- WARNINGS
- PRECAUTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56 gm Tube Label
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INGREDIENTS AND APPEARANCE
TAKE HOME FLUORIDE COOL MINT
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-1006 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Anhydrous Citric Acid (UNII: XF417D3PSL) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Xylitol (UNII: VCQ006KQ1E) Xanthan Gum (UNII: TTV12P4NEE) Glycerin (UNII: PDC6A3C0OX) Product Characteristics Color WHITE Score Shape Size Flavor MINT (Cool Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-1006-2 1 in 1 BOX, UNIT-DOSE 1 56 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/15/1997 Labeler - Patterson Dental Supply Inc (171843584)