KARLNHANS FRESH BREATH DOUBLE MINT- sodium monofluorophosphate paste, dentifrice

KarlnHans Fresh Breath Double Mint by

Drug Labeling and Warnings

KarlnHans Fresh Breath 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

Sorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Double-Mint Flavor, Cellulose Gum, Menthol, Stevioside, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract

PURPOSE

Caries prevention

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.

KEEP OUT OF REACH OF CHILDREN

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

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).

Directions

■ Brushing the teeth with a suitable amount

Other information

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

Questions

Questions

■ www.karlnhans.com | Customer center : 02-3451-2000

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KARLNHANS FRESH BREATH DOUBLE MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78151-100
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: 78151-100-02	1 in 1 CARTON	06/01/2025
1	NDC: 78151-100-01	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	06/01/2025

Labeler - PIGEON CORPORATION (687877613)

Registrant - PIGEON CORPORATION (687877613)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(78151-100)