KARL AND HANS BOTANIC JASMINE- sodium monofluorophosphate paste, dentifrice 
PIGEON CORPORATION

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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Drug Facts

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.74%

INACTIVE INGREDIENT

D-Sorbitol Solution, Concentrated Glycerin, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Jasmine Flavor, Xylitol, Sodium Carboxymethylcellulose, Enzymatically Modified Stevia, Jasmine Mint Flavor, Titanium Oxide, Spearmint Oil, Aluminium Chlorohydroxy Allantoinate, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Taraxacum, officinale Extract, Clove extract, Moutan Root Extract

PURPOSE

Caries prevention

WARNINGS

■ Contains 977ppm 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 mouth clean.
■ Prevents tooth decay caused by fluoride and removes bad breath.
■ Increases aesthetic effect.
■ 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℃)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

KARL AND HANS BOTANIC JASMINE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78151-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.74 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78151-020-021 in 1 CARTON05/01/2022
1NDC:78151-020-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2022
Labeler - PIGEON CORPORATION (687877613)
Registrant - PIGEON CORPORATION (687877613)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(78151-020)

Revised: 5/2022
Document Id: 80c164f6-8bda-4ea7-b5ff-ddbed2dc6959
Set id: 5faf03ac-8052-423b-af5f-eb62e7f63561
Version: 1
Effective Time: 20220525
 
PIGEON CORPORATION