![FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]](https://medic.hrt.org//dailymed/images/1a42cf2d-6c48-4e38-97bc-b6f2084bf39b/Tube Image.jpg)
| NDC | 51824-034-01, 51824-034-09 |
| Set ID | 1a42cf2d-6c48-4e38-97bc-b6f2084bf39b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | New World Imports, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART355 |
- OTC Active Ingredient
- OTC Purpose
- Keep out of reach of Children under 6 years of age
- Uses
- Warnings
-
Directions
Adults and children 2 years & older:
- Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
- Do not swallow.
- To minimize swallowing use a pea-sized amount in children under 6 years of age.
- Supervise children's brushing until good habits are established.
Children under 2 years:
- Ask a dentist
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FRESHMINT PREMIUM ANTICAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-034 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) POTASSIUM SODIUM SACCHARATE DIHYDATE (UNII: 6SI0K9D9KF) Sodium benzoate (UNII: OJ245FE5EU) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue (sky blue) Score Shape Size Flavor MINT (mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-034-01 130 g in 1 TUBE; Type 0: Not a Combination Product 04/04/2013 2 NDC:51824-034-09 8 g in 1 PACKET; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/04/2013 Labeler - New World Imports, Inc (075372276) Registrant - New World Imports, Inc (075372276)
