COLGATE TRILPLE ACCION- sodium fluoride paste, dentifrice 
GENESIS IMPORTS & EXPORTS LLC

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.

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ACTIVE INGREDIENT

Sodium Fluoride .34%

PURPOSE

Anticanity

USE

Helps protect against cavities

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.

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

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

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

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

Colgate

COLGATE TRILPLE ACCION 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-105
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen, whiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-105-014 in 1 PACKAGE04/17/2017
1150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69772-105-02150 mL in 1 TUBE; Type 0: Not a Combination Product04/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/17/2017
Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958)
Registrant - TERESA CECENA (078760958)
Establishment
NameAddressID/FEIBusiness Operations
GENESIS IMPORTS & EXPORTS LLC078760958relabel(69772-105)
Establishment
NameAddressID/FEIBusiness Operations
MISSION HILLS SA DE CV812312122manufacture(69772-105)

Revised: 4/2017
Document Id: 4d648add-ae3a-3716-e054-00144ff88e88
Set id: 4d648add-ae39-3716-e054-00144ff88e88
Version: 1
Effective Time: 20170417
 
GENESIS IMPORTS & EXPORTS LLC