Label: COLGATE TRILPLE ACCION- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69772-105-01, 69772-105-02 - Packager: GENESIS IMPORTS & EXPORTS LLC
- 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 April 17, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USER SAFETY WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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INDICATIONS & USAGE
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: use only a pea sized amount and supervise child's brushing and rising ( to minimize swallowing)
children under 2 years L ask a dentist or physician
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
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: use only a pea sized amount and supervise child's brushing and rising ( to minimize swallowing)
children under 2 years L ask a dentist or physician
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLGATE TRILPLE ACCION
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-105 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.32 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PIGMENT GREEN 7 (UNII: BPO9294G4W) EUGENOL (UNII: 3T8H1794QW) Product Characteristics Color green, white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-105-01 4 in 1 PACKAGE 04/17/2017 1 150 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69772-105-02 150 mL in 1 TUBE; Type 0: Not a Combination Product 04/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/17/2017 Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958) Registrant - TERESA CECENA (078760958) Establishment Name Address ID/FEI Business Operations GENESIS IMPORTS & EXPORTS LLC 078760958 relabel(69772-105) Establishment Name Address ID/FEI Business Operations MISSION HILLS SA DE CV 812312122 manufacture(69772-105)
