MOON CHARCOAL WHITENING ANTICAVITY- sodium fluoride paste

Moon Charcoal Whitening Anticavity by

Drug Labeling and Warnings

Moon Charcoal Whitening Anticavity by is a Otc medication manufactured, distributed, or labeled by Moon Oral Care, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Use aids 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 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 with supervised brushing to minimize swallowing.

WARNINGS

Warning

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

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

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

INGREDIENTS AND APPEARANCE

MOON CHARCOAL WHITENING ANTICAVITY 
sodium fluoride paste

Product 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)