Label: MINT DENTISTRY- charcoal spearmint paste
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Contains inactivated NDC Code(s)
NDC Code(s): 73333-115-01 - Packager: Nutrix International, 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 May 10, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
- WARNING
- KEEP OUT OF REACH SECTION
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DIRECTIONS
Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). For children under 2 years of age: Ask a dentist or doctor. - INACTIVE INGREDIENTS
- QUESTIONS?
- Dosage and Administration
- Package
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INGREDIENTS AND APPEARANCE
MINT DENTISTRY
charcoal spearmint pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73333-115 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2938 g in 113 g Inactive Ingredients Ingredient Name Strength STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) 0.3955 g in 113 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 23.73 g in 113 g GLYCERIN (UNII: PDC6A3C0OX) 31.753 g in 113 g WATER (UNII: 059QF0KO0R) 16.3285 g in 113 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.8532 g in 113 g ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) 0.565 g in 113 g XYLITOL (UNII: VCQ006KQ1E) 11.3 g in 113 g XANTHAN GUM (UNII: TTV12P4NEE) 0.452 g in 113 g SPEARMINT OIL (UNII: C3M81465G5) 1.469 g in 113 g SORBITOL (UNII: 506T60A25R) 24.86 g in 113 g Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73333-115-01 113 g in 1 TUBE; Type 0: Not a Combination Product 04/19/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/19/2020 Labeler - Nutrix International, LLC. (117341868) Registrant - Nutrix International, LLC. (117341868) Establishment Name Address ID/FEI Business Operations Nutrix International, LLC 117341868 manufacture(73333-115) , pack(73333-115) , label(73333-115)
Glycerin, Sorbitol, Hydrated Silicas, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Mentha Viridis (Spearmint) Leaf Oil, Stevia Rebaudiana Leaf /Steam Extract, Xanthan Gum, Activated Charcoal.
