PINE SALT 170G- sodium fluoride paste, dentifrice

PINE SALT 170g by

Drug Labeling and Warnings

PINE SALT 170g by is a Otc medication manufactured, distributed, or labeled by HANUL TRADING CO., LTD., AMOREPACIFIC, KOCO TRADING CO., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: SODIUM FLUORIDE (0.22%)

INACTIVE INGREDIENT

Inactive Ingredients: WATER, SORBITOL, HYDRATED SILICA, COCAMDOPROPYL BETAINE, PEG-32, CELLULOSE GUM, SODIUM LAURYL SULFATE, PINUS SYLVESTRIS CONE EXTRACT, FRAGRANCE, ZEOLITE, MENTHOL, SODIUM CHLORIDE, TRANEXAMIC ACID, SODIUM SACCARIN, METHYLPARABEN, SODIUM METHYL COCOYL TAURATE, SODIUM HYDROXIDE, SODIUM BENZOATE, TITANIUM DIOXIDE, CI 47005, CI 42090

PURPOSE

Purpose: Anticavity

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

USE

USE: Aids in the prevention of dental cavities

Directions

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PINE SALT 170G 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69642-1100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.374 g  in 170 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69642-1100-1	170 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2015

Labeler - HANUL TRADING CO., LTD. (689512982)

Registrant - HANUL TRADING CO., LTD. (689512982)

Establishment
Name	Address	ID/FEI	Business Operations
HANUL TRADING CO., LTD.		689512982	repack(69642-1100)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC		687995683	manufacture(69642-1100)

Establishment
Name	Address	ID/FEI	Business Operations
KOCO TRADING CO., INC.		079457993	wholesale drug distributor(69642-1100)