Label: MOON PLATINUM ADVANCED WHITENING ANTICAVITY- sodium fluoride paste

  • NDC Code(s): 82214-001-01, 82214-001-02
  • Packager: Moon Oral Care LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity

  • PURPOSE

    UseAids in the prevention of dental cavities

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.If more than than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.

  • WARNINGS

    Warning

    Contains Sodium Fluoride. In case of intake of flouride from other sources consult a dentist or doctor.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and older:

    • brush teeth thoroughly after meals 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
  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Water, Hydrated Silica, Xylitol, Flavor, hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Sodium Saccharin,

  • PRINCIPAL DISPLAY PANEL

    Moon Platinum

    Advanced Whitening

    Fluoride

    Premium Freshening

    Anticavity Toothpaste

    Platinum Mint

    119 g Net Wt. 4.2 OZ

    moon Plat Fluoride Paste

  • INGREDIENTS AND APPEARANCE
    MOON PLATINUM ADVANCED WHITENING ANTICAVITY 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82214-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MENTHOL (UNII: L7T10EIP3A)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SLOE (UNII: 3MLB4858X7)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SEA SALT (UNII: 87GE52P74G)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82214-001-021 in 1 CARTON01/25/2022
    1NDC:82214-001-01119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/25/2022
    Labeler - Moon Oral Care LLC (018021163)
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