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| Product NDC Code | 82214-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Moon whitening anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1489127 | ||||
| Application Number | M022 | ||||
| Labeler Name | Moon Oral Care, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing.
Purpose
Information about the drug product’s indications for use.Use: Aids in the prevention of dental cavities
Spl product data elements
Usually a list of ingredients in a drug product.Moon Whitening Anticavity Sodium Fluoride HYDRATED SILICA MICA WATER PEPPERMINT OIL TEA TREE OIL ASIAN GINSENG SORBITOL GLYCERIN SEA SALT MYRCIARIA DUBIA FRUIT HYDROGEN PEROXIDE SODIUM FLUORIDE FLUORIDE ION CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GREEN TEA LEAF SACCHARIN SODIUM ECHINACEA ANGUSTIFOLIA LEAF XYLITOL SODIUM LAUROYL SARCOSINATE TITANIUM DIOXIDE CARRAGEENAN MENTHA ARVENSIS LEAF OIL CRANBERRY SEED OIL COCONUT OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Tube
Outer
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API