NATURES SMILE

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Widepipe Corp
NDC Code: 76454-101

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 ingredients
Sodium monofluorophosphate  (0.84%)


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.

Purpose

Mouthwash that aids in the prevention of dental cavities


Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients  water,sodium saccharin, sodium hydroxide,hydrogenated castor oil, triclosan.


    Adults and children 2 years and older:  brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor
    instruct children under 6 years   in good brushing and rinsing habits (to minimize swallowing)
    supervise children as necessary until capable of using without supervision
    children under 2 years ask a dentist or physician


.

NATURES SMILE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76454-101
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
WATER 
TRICLOSAN 
HYDROGENATED CASTOR OIL 
Packaging
#Item CodePackage Description
1NDC:76454-101-01250 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/201110/01/2018
Labeler - Widepipe Corp (029799329)
Establishment
NameAddressID/FEIOperations
Widepipe Corp029799329manufacture, label

Revised: 04/2012
 
Widepipe Corp

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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