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| Product NDC Code | 70766-003 | ||||||||||||||||||||||||||||
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| Drug Name | Amerfresh |
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| Type | Brand | ||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||
| Dosage Form | PASTE | ||||||||||||||||||||||||||||
| Application Number | M021 | ||||||||||||||||||||||||||||
| Labeler Name | Yangzhou SION Commodity Co.,Ltd | ||||||||||||||||||||||||||||
| 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.Active ingredients Sodium monofluorophosphate 0.22%(0.1 w/v Fluoride ion) Purpose 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 do not swallow . supervise children as necessary until capable of useing 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 a physician. 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.INACTIVE INGREDIENT calcium carbonate,water,sorbitol,hydrated silica,sodium lauryl sulfate,sodium carboxymethyl cellulose,flavor,sodium sacharine,polymethylene glycol,guar gum,methylisothiazolinone.
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.Uses aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Amerfresh Sodium Fluoride GUAR GUM POTASSIUM SODIUM SACCHARATE CALCIUM CARBONATE SORBITOL HYDRATED SILICA METHYLENE GLYCOL WATER SODIUM LAURYL SULFATE DISODIUM CARBOXYMETHYLARSONATE METHYLISOTHIAZOLINONE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION
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.1
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.
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.Warnings 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. Keep out of reach of children.
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