MOON PLATINUM ADVANCED WHITENING ANTICAVITY- sodium fluoride paste

Moon Platinum Advanced Whitening Anticavity by

Drug Labeling and Warnings

Moon Platinum Advanced 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 Purpose

Sodium Fluoride 0.24% (0.13% w/v fluoride ion)

PURPOSE

Anticavity

INDICATIONS & USAGE

Aids in the prevention of dental cavities.

WARNINGS

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

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

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

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.

INSTRUCTIONS FOR USE

Directions

adults and children 2 years and older:

• brush teeth thoroughly after meals 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, Water, Hydrated Silica, Xylitol, Faultheria Procumbens (Wintergreen) Leaf Oil, Hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Mentha Piperita (Peppermint) Oil, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Fluoride, Menthol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Propylene Glycol, Sodium Olivoyl Glutamate, Mica, Limonene, Cocos Nucifera (Coconut) Oil, Prunus Spinosa Fruit Extract, Vaccinium Macrocarpon (Cranberry) Seed Oil, Iron Oxides, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sea Salt, Camellia Sinensis Leaf Extract, Echinacea Angustifolia Leaf Extract, Myciaria Dubia Fruit Extract, Panax Ginseng Root Extract

QUESTIONS

1(800) 949-8108

www.moonoralcare.com

DOSAGE & ADMINISTRATION

Topical Paste

PRINCIPAL DISPLAY PANEL

Moon Platinum

Advanced Whitening

Fluoride

Premium Freshening

Anticavity Toothpaste

Platinum Mint

119 g Net Wt. 4.2 OZ

INGREDIENTS AND APPEARANCE

MOON PLATINUM ADVANCED WHITENING ANTICAVITY 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82214-001
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
CELLULOSE GUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MENTHOL (UNII: L7T10EIP3A)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
KAOLIN (UNII: 24H4NWX5CO)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCONUT OIL (UNII: Q9L0O73W7L)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SEA SALT (UNII: 87GE52P74G)
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
CAMELLIA SINENSIS LEAF OIL (UNII: VC855RRT77)
GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF OIL (UNII: LAV5U5022Y)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SLOE (UNII: 3MLB4858X7)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM OLEOYL GLUTAMATE (UNII: D9L473B4SS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82214-001-02	1 in 1 CARTON	01/25/2022
1	NDC: 82214-001-01	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	01/25/2022

Labeler - Moon Oral Care LLC (018021163)