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

Teen Toothpast e Peach Leaf Flavor by

Drug Labeling and Warnings

Teen Toothpast e Peach Leaf Flavor by is a Otc medication manufactured, distributed, or labeled by MGRU, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TEEN TOOTHPAST E PEACH LEAF FLAVOR 
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81307-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.758 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81307-050-02	1 in 1 CARTON	12/01/2020
1	NDC: 81307-050-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2020

Labeler - MGRU (695672240)

Registrant - MGRU (695672240)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(81307-050)