KARL AND HANS BOTANIC JASMINE- sodium monofluorophosphate paste, dentifrice

Karl and Hans Botanic Jasmine by

Drug Labeling and Warnings

Karl and Hans Botanic Jasmine by is a Otc medication manufactured, distributed, or labeled by PIGEON CORPORATION, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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℃)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KARL AND HANS BOTANIC JASMINE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78151-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.74 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78151-060-02	1 in 1 CARTON	07/01/2024
1	NDC: 78151-060-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2024

Labeler - PIGEON CORPORATION (687877613)

Registrant - PIGEON CORPORATION (687877613)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(78151-060)