OSSTEM G GUM HEALTH CARE TOOTH- sodium fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Sodium Fluoride 0.22%

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses

Aids in the prevention of dental cavities

WARNINGS

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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DOSAGE & ADMINISTRATION

Directions

■ Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) ■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years : Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information

Store at 1~30°C (34~86°F)

QUESTIONS

Questions

+82-1660-0675

info@osstempharma.com

INACTIVE INGREDIENT

Inactive ingredients

Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, PEG-32, Menthol, Potassium Acesulfame, Tocopheryl Acetate, Xylitol, Panthenol, Centella Asiatica Extract, Citral, d-Limonene, Linalool

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OSSTEM G GUM HEALTH CARE TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87548-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-32 (UNII: 1212Z7S33A)
LINALOOL (UNII: D81QY6I88E)
CELLULOSE GUM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM ACESULFAME (UNII: 23OV73Q5G9)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
CITRAL (UNII: T7EU0O9VPP)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87548-020-02	1 in 1 CARTON	04/01/2026
1	NDC: 87548-020-01	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	04/01/2026

Labeler - Osstem Pharma Co., Ltd (696467325)

Registrant - Osstem Pharma Co., Ltd (696467325)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(87548-020)