100 TOOTHPAST E NIGHT- sodium monofluorophosphate gel, dentifrice

100 toothpast e Night by

Drug Labeling and Warnings

100 toothpast e Night 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 0.75%

INACTIVE INGREDIENTS

D-Sorbitol Solution, Aqua, Silicon Dioxide, Chamomile Extract, Rhatany Essence, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Peppermint Oil, Aqua Mint Flavor, Grapefruit Seed Extract, L-Menthol, Aluminium Chlorohydroxy Allantoinate, Xylitol, Enzymatically Modified Stevia, Green Tea Extract, Aloe Extract, Eucalyptus Extract, Sage Extract

PURPOSE

Nourishing, Soothing

WARNINGS

Adults and children 2 years of age and older: apply a 1-inch strip of product onto a toothbrush. Brush teeth thoroughly for 3 minutes three times a day (morning, afternoon, evening) or as recommended by a dentist. Do not swallow.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Provides a protection and relief action for healthier teeth and gum.
■ Helps fight and protect against cavities for healthier teeth.

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 only 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

100 TOOTHPAST E NIGHT 
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81307-030
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81307-030-02	1 in 1 CARTON	12/01/2020
1	NDC: 81307-030-01	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(81307-030)