MONGDIES SPEARMINT ADULT TOOTH- sodium monofluorophosphate paste, dentifrice 
360Perspective Inc.

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 0.6%

PURPOSE

Anti-plaque

WARNINGS

1. For adults only. 2. Be careful not to swallow, and rinse mouth thoroughly after use. 3. If any abnormality occurs such as gums or mouth injuries with this toothpaste, discontinue use and consult a doctor or dentist.4. If a child under the age of 7 swallows a large amount, consult a doctor or dentist immediately. 5. Keep out of the reach of children under 7 years of age.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 7 years of age.

Uses

It Keeps teeth white and firm. It Keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes the bad breath. It Increases the aesthetic effect. Removing plaque (anti-plaque), Prevention of gingivitis, periodontitis (gingivitis), periodontal disease, gum disease.

Directions

Apply a proper amount of toothpaste to the toothbrush and brush your teeth.

INACTIVE INGREDIENTS

Silicon Dioxide, Sodium pyrophosphate, Pyridoxine hydrochloride, L-Menthol, glycerin, Camellia sinensis leaf extract, Rosemary extract, Mastic, Cellulose gum, Sodium methyl cocoyl taurate, Sorbitol solution, PARFUM, Sodium Chloride, Xylitol, Purified water, Calendula extract, Chamomile extract, Peppermint oil, Propolis extract, Scutellaria Baicalensis root extract, Enzyme treatment Stevia

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

MONGDIES SPEARMINT ADULT TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Sodium pyrophosphate (UNII: O352864B8Z)  
Pyridoxine hydrochloride (UNII: 68Y4CF58BV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70477-060-021 in 1 CARTON09/01/202103/01/2022
1NDC:70477-060-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/202103/01/2022
Labeler - 360Perspective Inc. (689606142)
Registrant - 360Perspective Inc. (689606142)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70477-060)

Revised: 5/2023
 
360Perspective Inc.