MOON WHITENING GEL ANTICAVITY- sodium fluoride gel, dentifrice 
Moon Oral Care, LLC

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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.

Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity

Keep out of reach of children under 6 years of age. If more than used for brushin 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 brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Use: Aids in the prevention of dental cavities.

Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract

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

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MOON WHITENING GEL ANTICAVITY 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82214-004
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
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MICA (UNII: V8A1AW0880)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SORBITOL (UNII: 506T60A25R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SEA SALT (UNII: 87GE52P74G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
CARVONE, (+/-)- (UNII: 75GK9XIA8I)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
VANILLIN (UNII: CHI530446X)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82214-004-021 in 1 CARTON03/01/2022
1NDC:82214-004-01119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/01/2022
Labeler - Moon Oral Care, LLC (018021163)

Revised: 12/2023
Document Id: 0c556a29-a698-3a66-e063-6394a90abfee
Set id: 0c556a29-a697-3a66-e063-6394a90abfee
Version: 1
Effective Time: 20231212
 
Moon Oral Care, LLC