Label: MOON WHITENING GEL ANTICAVITY- sodium fluoride gel, dentifrice
- NDC Code(s): 82214-004-01, 82214-004-02
- Packager: Moon Oral Care, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
- WARNINGS
- ACTIVE INGREDIENT
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KEEP OUT OF REACH OF CHILDREN
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.
- PURPOSE
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INACTIVE INGREDIENT
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
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOON WHITENING GEL ANTICAVITY
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82214-004 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82214-004-02 1 in 1 CARTON 03/01/2022 1 NDC:82214-004-01 119 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 03/01/2022 Labeler - Moon Oral Care, LLC (018021163)
