Label: UNPASTE- zero waste fluoride mint tooth tabs tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 74355-212-01, 74355-212-02 - Packager: Avespan LLC
- 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 January 9, 2022
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
UNPASTE
zero waste fluoride mint tooth tabs tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74355-212 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.62 mg in 312 mg Inactive Ingredients Ingredient Name Strength STEVIA LEAF (UNII: 6TC6NN0876) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINT (UNII: FV98Z8GITP) MENTHOL, (+)- (UNII: C6B1OE8P3W) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor PEPPERMINT Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74355-212-01 125 in 1 PACKET 01/10/2022 1 312 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:74355-212-02 10000 in 1 CARTON 01/10/2022 2 312 mg in 1 BOX, UNIT-DOSE; 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 01/10/2022 Labeler - Avespan LLC (117415511) Establishment Name Address ID/FEI Business Operations Farmina sp. z.o.o. 422254391 manufacture(74355-212)