NATURES SMILE - sodium fluoride mouthwash
Widepipe Corp

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

image front and back of bottle

NATURES SMILE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76454-101
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
TRICLOSAN (UNII: 4NM5039Y5X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76454-101-01	250 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/01/2011	10/01/2018

Labeler - Widepipe Corp (029799329)

Name	Address	ID/FEI	Business Operations
Establishment
Widepipe Corp		029799329	manufacture, label

Revised: 4/2012

Document Id: 8fa43213-34bb-4291-9560-ed59d4daf16b

Set id: 32d0071a-b16e-4450-9528-88a78847dc08

Version: 1

Effective Time: 20120410

Widepipe Corp