MOON WHITENING GEL ANTICAVITY- sodium fluoride gel, dentifrice

Moon Whitening Gel Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

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

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

Use: Aids in the prevention of dental cavities.

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

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOON WHITENING GEL ANTICAVITY 
sodium fluoride gel, dentifrice

Product 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)