100 TOOTHPAST E MORNING- 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 0.75%

INACTIVE INGREDIENTS

D-Sorbitol Solution, Aqua, Silicon Dioxide, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, L-Menthol, Peppermint Oil, Aloe Extract, Spearmint Oil, Titanium Oxide, Soda Flavor, Xylitol, Enzymatically Modified Stevia, Grapefruit Seed Extract,Hydroxyapatite, Sage Extract, Chamomile Extract

PURPOSE

Anti cavity

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

■ Helps fight and protect against cavities for healthier teeth.

■ Refreshes your day with a strong mint flavor, which leaves your 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 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

Image of carton

100 TOOTHPAST E MORNING 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81307-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81307-010-021 in 1 CARTON12/01/2020
1NDC:81307-010-01100 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(81307-010)

Revised: 12/2020
Document Id: c602c35e-28e6-493b-ac6c-1ce56efbd187
Set id: 2a1ca442-c785-47ba-9d7b-d5ea9025c3d1
Version: 1
Effective Time: 20201223
 
MGRU