MOON CHARCOAL WHITENING ANTICAVITY- sodium fluoride paste 
Moon Oral Care, LLC

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

Use aids in the prevention of dental cavities

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

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

Warning

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

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

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

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MOON CHARCOAL WHITENING ANTICAVITY 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82214-003
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82214-003-021 in 1 CARTON01/01/2021
1NDC:82214-003-01119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/01/2021
Labeler - Moon Oral Care, LLC (018021163)

Revised: 12/2023
Document Id: 0c55f7b3-fea2-58f3-e063-6394a90a3bde
Set id: 0c55f7b3-fea1-58f3-e063-6394a90a3bde
Version: 1
Effective Time: 20231212
 
Moon Oral Care, LLC