Label: PINE SALT 140G- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69642-1200-1 - Packager: HANUL TRADING CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 24, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- USE
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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
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INGREDIENTS AND APPEARANCE
PINE SALT 140G
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69642-1200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.308 g in 140 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:69642-1200-1 140 g in 1 CARTON; Type 0: Not a Combination Product 02/01/2015 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 AMOREPACIFIC CORPORATION 694894112 manufacture(69642-1200) Establishment Name Address ID/FEI Business Operations KOCO TRADING CO., INC. 079457993 repack(69642-1200)
