TEEN TOOTHPAST E PEACH LEAF FLAVOR- sodium monofluorophosphate gel, dentifrice 
MGRU

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 Monofluorophosphate 0.758%

INACTIVE INGREDIENTS

Precipitated Calcium Carbonate, D-Sorbitol Solution, Water, Hydroxyapatite, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthangum, Xylitol, Peach Leaf Mint Flavor, L-Menthol, Enzymatically Modified Stevia, Sodium Chloride, Grapefruit Seed Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Chamomile Extract, Green Tea Extract

PURPOSE

Anti cavity

WARNINGS

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 immediately.

KEEP OUT OF REACH OF CHILDREN

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

Uses

■ Helps fight and protect against cavities for healthier teeth.
■ Refreshes a day with eucalyptus flavor, which leaves the mouth feeling fresh and clean.

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly. preferably .after each meal or three times a day, or as directed by a dentist or physician
■ Children 2 to 6 years: Use a pea sized amount and supervise child's brushing and rinsing. (to minimize swallowing)
■ Children under 2 years: Consult a dentist.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TEEN TOOTHPAST E PEACH LEAF FLAVOR 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81307-050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.758 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate (UNII: H0G9379FGK)  
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81307-050-021 in 1 CARTON12/01/2020
1NDC:81307-050-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2020
Labeler - MGRU (695672240)
Registrant - MGRU (695672240)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(81307-050)

Revised: 12/2020
Document Id: 384880e8-018f-4035-a4fc-0517524ca2a5
Set id: ddc442ce-1660-48b1-81b0-cadbeda12911
Version: 1
Effective Time: 20201223
 
MGRU