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CREST ANTI-CAVITY

Medically reviewed on March 31, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.45g in 100mL
Labeler: GENESIS IMPORTS & EXPORTS LLC
NDC Code: 69772-130

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 .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

  • adults and children 2 yrs & older; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sides amount in children under 6
  • supervise children's brushiong until goog habits are established
  • children under 2 yrs ask a dentist

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

CREST ANTI-CAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-130
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.45 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
EUGENOL 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE 
SORBITOL 
WATER 
HYDRATED SILICA 
SACCHARIN SODIUM 
XANTHAN GUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69772-130-011 TUBE in 1 CARTON
1100 mL in 1 TUBE
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/FEIOperations
genesis imports & exports llc078760958relabel(69772-130)
Establishment
NameAddressID/FEIOperations
Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(69772-130)

 
GENESIS IMPORTS & EXPORTS LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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