Label: MIPASTE PLUS MELON paste, dentifrice
- NDC Code(s): 61596-804-10, 61596-804-40, 61596-804-41
- Packager: GC America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 27, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Keep out of reach of children under 6 years of age.
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. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• adults and children over 12:
brush teeth with your normal
toothpaste at least twice a day, or
as directed by your dental
professional or doctor, rinse
mouth after brushing, dispense a
pea-sized portion of MI Paste Plus
onto your finger, apply thoroughly,
coating the upper teeth with an
even layer, repeat for lower teeth,
allow to remain on teeth for 3
minutes. Do not rinse.
• children under the age of 12:
consult your dental professional or
doctor -
INACTIVE INGREDIENT
Inactive ingredients
Butyl p-hydroxybenzoate, Casein
phosphopeptides and amorphous calcium
phosphate, D-sorbitol, Ethyl p-hydroxybenzoate,
Flavoring, Glycerol, Phosphoric acid, Propyl
p-hydroxybenzoate, Propylene glycol, Silicon
dioxide, Sodium carboxymethyl cellulose, Sodium
saccharin, Titanium dioxide, Water, Xylitol - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MIPASTE PLUS MELON
mipaste plus melon paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61596-804 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLPARABEN (UNII: 3QPI1U3FV8) CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX) GLYCERIN (UNII: PDC6A3C0OX) PHOSPHORIC ACID (UNII: E4GA8884NN) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61596-804-10 10 in 1 BOX 02/03/2022 1 NDC:61596-804-41 1 in 1 BOX, UNIT-DOSE 1 NDC:61596-804-40 40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological 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) Registrant - GC America Inc. (005473608) Establishment Name Address ID/FEI Business Operations GC America Inc. 005473608 manufacture(61596-804)
