Label: MIPASTE ONE paste, dentifrice
- NDC Code(s): 61596-400-10, 61596-400-40, 61596-400-41
- Packager: GC America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 27, 2024
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. If more than the recommended amount of paste used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use on patients with a milk protein or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.
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DOSAGE & ADMINISTRATION
For adults and children 12 years of age or older, apply a small, pea-size amount of MI Paste One to your toothbrush. For best results, brush for 2 minutes, expectorate and do not rinse; do not eat or drink for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 12 years of age, consult a dentist or physician.
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INACTIVE INGREDIENT
Inactive ingredient Pure water, Glycerol, RECALDENT (CPP-ACP), Casein Phosphopeptide-Amorphous, Calcium Phosphate, Sorbitol, CMC-NA, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, Sodium saccharin, Ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Butyl p-hydroxybenzoate, Sodium-N-lauroyl sarcosinate
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIPASTE ONE
mipaste one paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61596-400 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYL SALICYLATE (UNII: LAV5U5022Y) ETHYLPARABEN (UNII: 14255EXE39) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) PHOSPHORIC ACID (UNII: E4GA8884NN) BUTYLPARABEN (UNII: 3QPI1U3FV8) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61596-400-10 10 in 1 BOX 02/03/2022 1 NDC:61596-400-41 1 in 1 BOX 1 NDC:61596-400-40 46 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 Drug M021 02/03/2022 Labeler - GC America Inc. (005473608) Establishment Name Address ID/FEI Business Operations GC America Inc. 005473608 manufacture(61596-400)