Label: MOON WHITENING ANTICAVITY- sodium fluoride paste
- NDC Code(s): 82214-002-01, 82214-002-02
- Packager: Moon Oral Care, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
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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
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
MOON WHITENING ANTICAVITY
sodium fluoride pasteProduct 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)
