Moon Whitening Gel Anticavity

Manufacturer
Moon Oral Care, LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:04:10

Label at a glance#

ProductMoon Whitening Gel Anticavity
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 2 years and older:

Brush teeth thoroughly after meals or 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.

WARNINGS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushin is accidentally swallowed, get medical help or contact a Poison Control Center right away. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

OTC - PURPOSE SECTION

Use: Aids in the prevention of dental cavities.

INACTIVE INGREDIENT SECTION

Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterOuter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82214-004-01Moon Whitening Gel Anticavity119 g in 1 TUBEGEL, DENTIFRICE1191
82214-004-02Moon Whitening Gel Anticavity1 in 1 CARTONGEL, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82214-004MOON WHITENING GEL ANTICAVITY (SODIUM FLUORIDE) GEL, DENTIFRICE [MOON ORAL CARE, LLC]1Current NDC, 2 package rows20231214_0c556a29-a697-3a66-e063-6394a90abfee.zip

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
82214-00482214-004-01, 82214-004-02

Ingredients#

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

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

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 Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
ndc (package): 82214-004-02
ndc (package): 82214-004-01
ndc (product): 82214-004
ndc11 (package): 82214000402
ndc11 (package): 82214000401
spl id: 0c556a29-a698-3a66-e063-6394a90abfee
spl set id: 0c556a29-a697-3a66-e063-6394a90abfee

Reported adverse events (FAERS/openFDA)#

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