SONGYUM NEW PINESALT- sodium fluoride paste
AMOREPACIFIC CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SONGYUM New Pinesalt fluoride toothpaste 90 g

Drug Facts

ACTIVE INGREDIENTS

SODIUM FLUORIDE 0.22 % (1000 ppm/ 0.1% w/v fluoride ion)

PURPOSE

Anticavity

USE

Aids in the prevention of dental cavities

WARNINGS

Keep out of the 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.

DIRECTIONS

Adults and children 2 years of age and older; brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or doctor. 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 of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

WATER, SORBITOL, HYDRATED SILICA, COCAMIDOPROPYL BETAINE, PEG-32, CELLULOSE GUM, SODIUM LAURYL SULFATE, ZEOLITE, MENTHOL, SODIUM SACCHARIN, SODIUM CHLORIDE, METHYLPARABEN, SODIUM METHYL COCOYL TAURATE, SODIUM HYDROXIDE, SODIUM BENZOATE, TRANEXAMIC ACID, PINUS SYLVESTRIS CONE EXTRACT, FRAGRANCE, TITANIUM DIOXIDE, YELLOW 10 (CI 47005), BLUE 1 (CI) 42090

PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

SONGYUM New Pinesalt
fluoride toothpaste 90 g
NET WT. 3.17 oz/90 g

LOHAS
Lifestyles Of Health And
Sustainability

Principal Display Panel - 90 g Tube Carton

SONGYUM NEW PINESALT
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-901
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.198 g in 90 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
PINUS SYLVESTRIS CONE (UNII: 856B44M480)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-901-23	1 in 1 CARTON	03/05/2013	09/20/2018
1		90 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	03/05/2013	09/20/2018

Labeler - AMOREPACIFIC CORPORATION (631035289)

Revised: 10/2018

Document Id: 9322e871-79e3-4c6b-aa9e-4bf80bbc0462

Set id: 6322ecd0-cb1d-4c0f-a312-a05e36f3cc25

Version: 2

Effective Time: 20181002

AMOREPACIFIC CORPORATION