Regular

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0012

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.

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.76% (0.15%w/v fluoride ion)

PurposeAnticavity

Usage

helps protect against cavities

Warnings

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Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right 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 years
use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years
ask a dentist or physician

Inactive ingredients

calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor

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REGULAR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0012
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
SORBITOL 
WATER 
SILICON DIOXIDE 
GLYCERIN 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
METHYLPARABEN 
AMINOCAPROIC ACID 
XYLITOL 
SACCHARIN SODIUM 
MENTHOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:67510-0012-41 TUBE (TUBE) in 1 BOX
1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/15/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 02/2012
 
Kareway Product, Inc.

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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