Label: COLGATE TRIPLE ACTION- sodium fluoride paste, dentifrice
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NDC Code(s):
35000-941-46,
35000-941-47,
35000-941-48,
35000-941-58, view more35000-941-60, 35000-941-63, 35000-941-64, 35000-941-69, 35000-941-79, 35000-941-82, 35000-941-92, 35000-941-99
- Packager: Colgate-Palmolive
- 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 10, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 232 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE TRIPLE ACTION
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-941 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) 220 mg in 1 g WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE, WHITE, GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-941-79 1 in 1 CARTON 12/01/2010 1 79 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-941-63 1 in 1 CARTON 12/01/2010 2 85 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-941-69 1 in 1 CARTON 12/01/2010 3 113 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:35000-941-46 1 in 1 CARTON 12/01/2010 4 130 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:35000-941-64 1 in 1 CARTON 12/01/2010 5 181 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:35000-941-82 1 in 1 CARTON 12/01/2010 6 232 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:35000-941-60 1 in 1 CARTON 12/01/2010 7 170 g in 1 TUBE; Type 0: Not a Combination Product 8 NDC:35000-941-48 1 in 1 CARTON 12/01/2010 8 226 g in 1 TUBE; Type 0: Not a Combination Product 9 NDC:35000-941-58 1 in 1 CARTON 12/01/2010 9 70 g in 1 TUBE; Type 0: Not a Combination Product 10 NDC:35000-941-92 1 in 1 CARTON 12/01/2010 10 141 g in 1 TUBE; Type 0: Not a Combination Product 11 NDC:35000-941-99 1 in 1 CARTON 11/09/2020 11 99 g in 1 TUBE; Type 0: Not a Combination Product 12 NDC:35000-941-47 1 in 1 CARTON 12/14/2020 12 133 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 12/01/2010 Labeler - Colgate-Palmolive (001344381) Registrant - Colgate-Palmolive Company (001344381)