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SONGYUM New Pinesalt

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.198g in 90g
Labeler: AMOREPACIFIC
NDC Code: 43419-901

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.

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

SONGYUM NEW PINESALT 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-901
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.198 g  in 90 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
COCAMIDOPROPYL BETAINE 
POLYETHYLENE GLYCOL 1500 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
MENTHOL 
SACCHARIN SODIUM 
SODIUM CHLORIDE 
METHYLPARABEN 
SODIUM METHYL COCOYL TAURATE 
SODIUM HYDROXIDE 
SODIUM BENZOATE 
TRANEXAMIC ACID 
PINUS SYLVESTRIS CONE 
TITANIUM DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:43419-901-231 TUBE in 1 CARTON
190 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35503/05/2013
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIOperations
AMOREPACIFIC687995683MANUFACTURE(43419-901)

Revised: 03/2013
 
AMOREPACIFIC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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