Label: COLGATE PROCLINICAL - SPARKLING MINT- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51442-543-69 - Packager: Colgate-Palmolive Canada
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 16, 2010
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Carton
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INGREDIENTS AND APPEARANCE
COLGATE PROCLINICAL - SPARKLING MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51442-543 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Hydrated Silica (UNII: Y6O7T4G8P9) Sorbitol (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) Polyethylene Glycol 600 (UNII: NL4J9F21N9) Sodium Tripolyphosphate (UNII: 5HK03SA80J) Sodium Pyrophosphate (UNII: O352864B8Z) Sodium Lauryl Sulfate (UNII: 368GB5141J) Carboxymethylcellulose Sodium (UNII: K679OBS311) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Sodium Hydroxide (UNII: 55X04QC32I) Saccharin Sodium (UNII: SB8ZUX40TY) Xanthan Gum (UNII: TTV12P4NEE) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Blue No. 1 (UNII: H3R47K3TBD) Product Characteristics Color WHITE (Blue Speckles) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51442-543-69 1 in 1 CARTON 1 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/10/2010 Labeler - Colgate-Palmolive Canada (259157246)