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COLGATE TRILPLE ACCION

Medically reviewed on April 17, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.32mg in 1mL
Labeler: GENESIS IMPORTS & EXPORTS LLC
NDC Code: 69772-105

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.

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 TRILPLE ACCION 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-105
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE 
XANTHAN GUM 
GLYCERIN 
HYDRATED SILICA 
WATER 
FD&C BLUE NO. 1 
SACCHARIN SODIUM 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
PIGMENT GREEN 7 
EUGENOL 
Product Characteristics
Colorgreen, whiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69772-105-014 TUBE in 1 PACKAGE
1150 mL in 1 TUBE
2NDC:69772-105-02150 mL in 1 TUBE
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/FEIOperations
GENESIS IMPORTS & EXPORTS LLC078760958relabel(69772-105)
Establishment
NameAddressID/FEIOperations
MISSION HILLS SA DE CV812312122manufacture(69772-105)

 
GENESIS IMPORTS & EXPORTS LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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