![FRESHMINT PREMIUM ANTICAVITY GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]](https://medic.hrt.org//dailymed/images/dfe564c1-2097-431d-93f0-cf423f254248/ADA Label.jpg)
| NDC | 51824-046-01, 51824-046-02, 51824-046-03, 51824-046-04 |
| Set ID | dfe564c1-2097-431d-93f0-cf423f254248 |
| 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 GEL
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-046 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) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color blue (Aqua Blue) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-046-02 144 in 1 CARTON 01/01/2015 1 NDC:51824-046-01 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51824-046-04 72 in 1 CARTON 01/01/2015 2 NDC:51824-046-03 85 g in 1 TUBE; 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 01/01/2015 Labeler - New World Imports, Inc (075372276)
