NEED FOR YOU LIMPIO TOOTH- sodium monofluorophosphate paste, dentifrice 
NEED FOR YOU

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 0.76%

INACTIVE INGREDIENTS

Sorbitol, Water, Sodium Cocoyl Glutamate, Cellulose Gum, Glycerin, Menthol, Mentha Piperita (Peppermint) Oil, Mentha Spicata Herb Oil, Herb Flavor, Stevioside, Hydroxyapatite, Xylitol, Citrus Grandis (Grapefruit) Seed Extract, Propolis Wax, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Eucalyptus Globulus Leaf Extract, Aloe Barbadensis Leaf Extract, Taraxacum Officinale (Dandelion) Rhizome, Ascorbic Acid

PURPOSE

Caries prevention

WARNINGS

■ Contains 1000ppm of fluoride.
■ Do not swallow and rinse mouth thoroughly after use
■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

■ Keep your teeth white and strong.
■ Keep your mouth clean.
■ Refresh the inside of the mouth.
■ Prevents tooth decay caused by fluoride and removes bad breath.
■ Increases aesthetic effect.
■ Prevention of gingivitis and periodontitis (alveolar fistula)
■ Prevention of periodontal disease
■ Prevention of gum disease
■ Prevention of plaque deposition, removal of plaque (anti-prag)

Directions

■ Brushing the teeth with a suitable amount

Other Information

Airtight container, Store in normal temperature (1~30℃)

QUESTIONS

■ +82-2-579-9693 / www.needforyou.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

NEED FOR YOU LIMPIO TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81373-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.91 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81373-010-021 in 1 CARTON12/01/2020
1NDC:81373-010-01120 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 - NEED FOR YOU (695126264)
Registrant - NEED FOR YOU (695126264)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD557810721manufacture(81373-010)

Revised: 12/2020
Document Id: 587f6611-d75e-4dde-aca2-ce0bc3dcbca3
Set id: 181d12b0-a1bf-4c5e-b7d1-7e0e8db95153
Version: 1
Effective Time: 20201230
 
NEED FOR YOU