CREST ANTI-CAVITY- 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 .243% (.15% w/v flouride ion)

Purpose

Anticavity toothpaste

WARNINGS AND PRECAUTIONS

kEEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE

KEEP OUT OF THE CHILDREN UNDER 6 YRS OF AGE.

If more than used for brishing is accidentally swallowed, get medical help or contact a poison control center rigth away.

DIRECTIONS

INACTIVE INGREDIENTS:

sorbitol,water,hydrated silica, sodium lauryl sulfate, trisosium phosphate, flavor, sodium phospahte, cellulose gum, sodium saccharin, carbomer, titanium dioxide

USE

Helps protect against cavities

KEEP OUT OF REACH OF CHILDREN UNDER 6 YTS OF AGE

C REST ANTI-CAVITY

CREST ANTI-CAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-130
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.45 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
EUGENOL (UNII: 3T8H1794QW)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69772-130-011 in 1 CARTON03/31/2017
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/31/2017
Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958)
Registrant - GENESIS IMPORTS & EXPORTS LLC (078760958)
Establishment
NameAddressID/FEIBusiness Operations
genesis imports & exports llc078760958relabel(69772-130)
Establishment
NameAddressID/FEIBusiness Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(69772-130)

Revised: 3/2017
Document Id: 4c0b52af-ac62-54d7-e054-00144ff88e88
Set id: 4c0b52af-ac61-54d7-e054-00144ff88e88
Version: 1
Effective Time: 20170331
 
GENESIS IMPORTS & EXPORTS LLC