KARL AND HANS BOTANIC DOUBLE MINT- sodium monofluorophosphate paste, dentifrice

Karl and Hans Botanic Double Mint by

Drug Labeling and Warnings

Karl and Hans Botanic Double Mint 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, Xylitol, Double Mint Flavor, Sodium Carboxymethylcellulose, Sodium Chloride, Double Mint Flavor, Titanium Oxide, Peppermint Oil, Aluminium Chlorohydroxy Allantoinate, Enzymatically Modified Stevia, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Houttuynia Cordata Extract, Sage 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 DOUBLE MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78151-040
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: 78151-040-02	1 in 1 CARTON	07/01/2024
1	NDC: 78151-040-01	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(78151-040)