Karl and Hans Botanic Double Mint

Manufacturer
PIGEON CORPORATION | DONG IL PHARMS CO., LTD.
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:59

Label at a glance#

ProductKarl and Hans Botanic Double Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and 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)

Dosage and administration

■ Brushing the teeth with a suitable amount

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.74%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Caries prevention

WARNINGS

WARNINGS SECTION

■ 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

■ 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

DOSAGE & ADMINISTRATION SECTION

■ Brushing the teeth with a suitable amount

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737795sodium monofluorophosphate 0.74 % ToothpastePSN2
1737795sodium monofluorophosphate 0.0074 MG/MG ToothpasteSCD2
1737795sodium monofluorophosphate 0.74 % ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78151-040-01Karl and Hans Botanic Double Mint120 g in 1 TUBEPASTE, DENTIFRICE1202
78151-040-02Karl and Hans Botanic Double Mint1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78151-040KARL AND HANS BOTANIC DOUBLE MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PIGEON CORPORATION]2Current NDC, 2 package rows20240809_d1233fc3-047c-4e26-bb2b-8ebde09c05a9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78151-04078151-040-01, 78151-040-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
ndc (package): 78151-040-02
ndc (package): 78151-040-01
ndc (product): 78151-040
ndc11 (package): 78151004002
ndc11 (package): 78151004001
spl id: 1f29a950-cf6b-1e8f-e063-6394a90ac921
spl set id: d1233fc3-047c-4e26-bb2b-8ebde09c05a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.