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) Anticavity

PURPOSE

UseAids 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 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 for supervised brushing to minimize swallowing.

WARNINGS

Warning

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

DOSAGE & ADMINISTRATION

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, Flavor, hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Sodium Saccharin,

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
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MENTHOL (UNII: L7T10EIP3A)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SLOE (UNII: 3MLB4858X7)
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)

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)