FDA.reportPublic FDA data

Moon Platinum Advanced Whitening Anticavity

Manufacturer
Moon Oral Care LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:34:31

Label at a glance#

ProductMoon Platinum Advanced Whitening Anticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

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

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

Topical Paste

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moon Platinum

Advanced Whitening

Fluoride

Premium Freshening

Anticavity Toothpaste

Platinum Mint

119 g Net Wt. 4.2 OZ

moon Plat Fluoride Pastemoon Plat Fluoride Paste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850000948839GTIN-13: 0850000948839
EAN-13: 0850000948839
GTIN-12: 850000948839
UPC-A: 850000948839
GTIN storage (14 digits): 00850000948839		MOON_PLAT_FLUORIDE_PASTE_BOX_USA_082421-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82214-001-01Moon Platinum Advanced Whitening Anticavity119 g in 1 TUBEPASTE1193
82214-001-02Moon Platinum Advanced Whitening Anticavity1 in 1 CARTONPASTE13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82214-00182214-001-01, 82214-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE GUMK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
CARRAGEENAN5C69YCD2YJIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
XYLITOLVCQ006KQ1EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MENTHOLL7T10EIP3AIACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
KAOLIN24H4NWX5COIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
MYRCIARIA DUBIA FRUITYSW4EM1EKPIACT
ASIAN GINSENGCUQ3A77YXIIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
COCONUT OILQ9L0O73W7LIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FERRIC OXIDE RED1K09F3G675IACT
SEA SALT87GE52P74GIACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CAMELLIA SINENSIS LEAF OILVC855RRT77IACT
GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF OILLAV5U5022YIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SLOE3MLB4858X7IACT
HYDROXYAPATITE91D9GV0Z28IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM OLEOYL GLUTAMATED9L473B4SSIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moon Platinum Advanced Whitening AnticavitySODIUM FLUORIDEMoon Oral Care LLCded3a5a6-2883-f3de-e053-2a95a90afb942026-01-09WarningsExact identifier
ndc (package): 82214-001-02
ndc (package): 82214-001-01
ndc (product): 82214-001
ndc11 (package): 82214000102
ndc11 (package): 82214000101
spl id: 47fb842b-036e-d34c-e063-6294a90a0111
spl set id: ded3a5a6-2883-f3de-e053-2a95a90afb94

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.