100 TOOTHPAST E NIGHT- 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, 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

Image of carton

100 TOOTHPAST E NIGHT 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81307-030
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:81307-030-021 in 1 CARTON12/01/2020
1NDC:81307-030-01100 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(81307-030)

Revised: 12/2020
Document Id: 0cc949b4-12b2-428a-8c46-98d45049873e
Set id: dca4a7ff-645f-4ead-ab42-0041ec4de495
Version: 1
Effective Time: 20201223
 
MGRU