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]

DOSAGE & ADMINISTRATION

Directions:

Adults and children 2 years and older:

Brush teeth thoroughly after meals or at least twice a a day or use as direfted 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

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.

INDICATIONS & USAGE

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

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.

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SEA SALT (UNII: 87GE52P74G)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
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)
COCONUT OIL (UNII: Q9L0O73W7L)

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)