Label: SCHMIDTS MINT AND BERRY KIDS TOOTH AND MOUTH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72916-312-05 - Packager: Schmidt's Naturals
- 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 June 12, 2019
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- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
Adults and children 2 years of age and older:
Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a Dentist or Physician.Children 2 to 6 years of age:
Instruct children under 6 years of age in good brushing and rinsing methods (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a Dentist or Physician.
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Inactive ingredients
Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sodium Methyl Cocoyl Taurate, Natural Flavor, Xanthan Gum, Cocos Nucifera (Coconut) Oil, Stevia Rebaudiana Leaf/Stem Powder, Aloe Barbadensis Leaf Extract, Magnolia Acuminata (Blue Magnolia) Bark Extract, Lycium Barbarum (Goji Berry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E, Sunflower Derived), Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.
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INGREDIENTS AND APPEARANCE
SCHMIDTS MINT AND BERRY KIDS TOOTH AND MOUTH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72916-312 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.026 g in 133 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) CALCIUM CARBONATE (UNII: H0G9379FGK) XYLITOL (UNII: VCQ006KQ1E) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) XANTHAN GUM (UNII: TTV12P4NEE) COCONUT OIL (UNII: Q9L0O73W7L) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) ALOE VERA LEAF (UNII: ZY81Z83H0X) MAGNOLIA ACUMINATA BARK (UNII: 2U55IJZ60C) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) POMEGRANATE (UNII: 56687D1Z4D) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TEA TREE OIL (UNII: VIF565UC2G) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white Score Shape Size Flavor MINT, BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72916-312-05 1 in 1 CARTON 06/20/2019 1 133 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 06/20/2019 Labeler - Schmidt's Naturals (088112308)
