MOON WHITENING ANTICAVITY- sodium fluoride paste

Moon Whitening Anticavity by

Drug Labeling and Warnings

Moon 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

Sodium Fluoride 0.23% (0.117% w/v fluoride ion) Anticavity

PURPOSE

Anticavity

DOSAGE & ADMINISTRATION

Topical Paste

INDICATIONS & USAGE

Aids in the prevention of dental cavities.

WARNINGS

Warning:

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

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

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.

INACTIVE INGREDIENT

WATER, SORBITOL, HYDRATED SILICA, GLYCERIN, XYLITOL, MICA, CELLULOSE GUM, SODIUM LAUROYL SARCOSINATE, TITANIUM DIOXIDE, SACCHARIN SODIUM, CARRAGEENAN, FLAVOR, MENTHA ARVENSIS LEAF OIL, PEPPERMINT OIL, COCONUT OIL, CRANBERRY SEED OIL, TEA TREE OIL, SEA SALT, GREEN TEA LEAF, ECHINACEA ANGUSTIFOLIA LEAF, MYRCIARIA DUBIA FRUIT, ASIAN GINSENG, HYDROGEN PEROXIDE, ALPHA-ISOMETHYL IONONE, ENZYL SALICYLATE, COUMARIN, LIMONENE

Primary Tube

Carton

INGREDIENTS AND APPEARANCE

MOON WHITENING ANTICAVITY 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82214-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
SEA SALT (UNII: 87GE52P74G)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
COCONUT OIL (UNII: Q9L0O73W7L)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82214-002-02	1 in 1 CARTON	07/01/2019
1	NDC: 82214-002-01	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	07/01/2019

Labeler - Moon Oral Care, LLC (018021163)