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| Product NDC Code | 65517-2005 | ||||||||||||||
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| Drug Name | Dawnmist |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||||||||||
| RxCUI drug identifier | 245598 | ||||||||||||||
| Application Number | M021 | ||||||||||||||
| Labeler Name | Dukal 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 0.22%
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.Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben
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.Aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.DawnMist Toothpaste WATER CALCIUM CARBONATE POLYETHYLENE GLYCOL 400 CARBOXYMETHYLCELLULOSE SODIUM SODIUM FLUORIDE FLUORIDE ION HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) METHYLPARABEN HYDRATED SILICA SODIUM LAURYL SULFATE SACCHARIN SODIUM PROPYLPARABEN
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.DawnMist NDC: 65517-2005-0 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 0.6 OZ. (17 g) RTP06
DawnMist NDC: 65517-2005-1 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 0.85 OZ. (24 g) RTP085
DawnMist NDC: 65517-2005-2 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 1.5 OZ. (43 g) RTP15
DawnMist NDC: 65517-2005-3 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 2.75 OZ. (78 g) RTP27
DawnMist NDC: 65517-2005-4 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 4.75 OZ. (134 g) RTP47B
DawnMist NDC: 65517-2005-5 Oral Care Fluoride Toothpaste FRESH MINT FLAVOR 6.4 OZ. (181 g) RTP64
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DawnMist Fluoride Toothpaste
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 the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.
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.Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.
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