COLGATE TRILPLE ACCION- sodium fluoride paste, dentifrice

COLGATE TRILPLE ACCION by

Drug Labeling and Warnings

COLGATE TRILPLE ACCION by is a Otc medication manufactured, distributed, or labeled by GENESIS IMPORTS & EXPORTS LLC, TERESA CECENA, MISSION HILLS SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Sodium Fluoride .34%

PURPOSE

PURPOSE

Anticanity

USER SAFETY WARNINGS

USE

Helps protect against cavities

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. If more that used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

WARNINGS

Keep outh of the reach of children under 6 years of age. if more than the used for brushing is accidentally swallowed, get medical help or contact a poison control center rigth away

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

water, hydrated silica, blue, sodium lauryl sulfate, cellusosa gum, sacchharin sodium, xanathan gum, titanium dioxide, glycerin, aroma,green #7, eugenol

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

INGREDIENTS AND APPEARANCE

COLGATE TRILPLE ACCION 
sodium fluoride paste, dentifrice

Product 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)