KarlnHans Fresh Breath Jasmine Mint
Drug Facts
384863bd-b2cb-a46d-e063-6394a90a3ce2
HUMAN OTC DRUG LABEL
Jun 23, 2025
PIGEON CORPORATION
DUNS: 687877613
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Monofluorophosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
■ Keep your teeth white and strong.
■ Keeps the oral cavity clean.
■ Refreshes the oral cavity.
■ Prevents cavities and eliminates bad breath.
■ Enhance the aesthetic effect.
■ Prevention of gingivitis, periodontitis (pyorrhoea), periodontal disease, prevention of gum disease.
■ Remove dental plaque (anti-prag).
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT
Sodium Monofluorophosphate 0.74%
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT
Sorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Jasmine Flavor, Menthol, Stevioside, Jasmine-Mint Flavor, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract
OTC - PURPOSE SECTION
PURPOSE
Caries prevention
WARNINGS SECTION
WARNINGS
■ Fluorine content of this product is 977ppm.
■ In the following cases, immediately stop using this product and consult a doctor or dentist.
(1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product.
(2) If a child under 6 years old swallows a large amount.
■ Other precautions when using this product.
(1) Be careful not to swallow it and rinse your mouth thoroughly after use.
(2) 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.
■ Precautions for storage.
(1) Keep out of the reach of children under 6 years of age.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN
■ Keep out of the reach of children under 6 years of age.
DOSAGE & ADMINISTRATION SECTION
Directions
■ Brushing the teeth with a suitable amount
OTHER SAFETY INFORMATION
Other information
■ Airtight container, Store in normal temperature (1~30℃)
OTC - QUESTIONS SECTION
Questions
■ www.karlnhans.com | Customer center : 02-3451-2000