Label: MOON CHARCOAL WHITENING ANTICAVITY- sodium fluoride paste
- NDC Code(s): 82214-003-01, 82214-003-02
- Packager: Moon Oral Care, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:
Adults and children 2 years and older:
brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 years: ask a dentist
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INACTIVE INGREDIENT
Inactive ingredients:
Glycerin, Hydrated Silica, Sorbitol, Water/Aqua/Eau, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Hexametaphosphate, Disodium Pyrophosphate, Stevia Rebaudiana Leaf Extract, Cocos Nucifera (Coconut) Oil, Mentha Piperita (Peppermint) Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Sea Salt, Echinacea Angustifolia Leaf Extract, Camellia Sinensis (Black and Green Teas) Leaf Extract, Panax Ginseng Root Extract, Mrciaria Dubia (Camu Camu) Fruit Extract, Carbon (Activated Charcoal), Sodium Benzoate, Titanium Dioxide, Chondrus Crispus Extract, Sodium Gluconate, Xanthan Gum, Sucralose, Citric Acid, Mica
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOON CHARCOAL WHITENING ANTICAVITY
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82214-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MICA (UNII: V8A1AW0880) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) COCONUT OIL (UNII: Q9L0O73W7L) TEA TREE OIL (UNII: VIF565UC2G) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ASIAN GINSENG (UNII: CUQ3A77YXI) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SEA SALT (UNII: 87GE52P74G) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM COCO-SULFATE (UNII: 3599J29ANH) SORBITOL (UNII: 506T60A25R) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM GLUCONATE (UNII: R6Q3791S76) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82214-003-02 1 in 1 CARTON 01/01/2021 1 NDC:82214-003-01 119 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 M022 01/01/2021 Labeler - Moon Oral Care, LLC (018021163)
