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| Product NDC Code | 69951-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Prevention oncology mouth rinse |
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| Type | Brand | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| Application Number | part356 | ||||||
| Labeler Name | Prevention Health Sciences, Inc. | ||||||
| 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 Glycerin 4.5%
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 of age and older: gargle, swish around in the mouth over the affected area for at least one minute and then spit out. Use as needed or as directed by dentist or doctor. children under 12 years of age should be supervised in the use of product. children under 2 : consult with a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, de-ionized water, disodium EDTA, hydrogen peroxide, menthol, peppermint oil, poloxamer 407, sodium citrate, xylitol, zinc chloride
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 for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
Purpose
Information about the drug product’s indications for use.Purpose Oral Demulcent
Spl product data elements
Usually a list of ingredients in a drug product.Prevention Oncology Mouth Rinse Glycerin GLYCERIN GLYCERIN CITRIC ACID MONOHYDRATE WATER EDETATE DISODIUM HYDROGEN PEROXIDE MENTHOL PEPPERMINT OIL POLOXAMER 407 SODIUM CITRATE ZINC CHLORIDE XYLITOL
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.ALCOHOL FREE PREVENTION MOUTH RINSE Formulated for Oncology Patients √ Soothes & Protects Oral Mucosa √ Provides Temporary Oral Pain Relief √ Hydrating Formula Soothing Mint NET. 16 FL OZ (1 PT) 473 ML label
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.Drug Facts
Formulated and Ditributed by: Prevention Health Sciences, Inc. Raleigh, IL 62977 800-473-1205 PHS Brands www.preventionhs.com
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product for more than 7 days unless directed by a dentist or physician
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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 800-473-1205
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • sore throat is severe • lasts for more than 2 days • is accompanied or followed by fever, headache, rash, nausea or vomiting • sore mouth symptoms do not improve in 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not swallow.
Storage and handling
Information about safe storage and handling of the drug product.Other information keep product away from heat or direct sunlight DO NOT USE IF SAFETY SEAL IS BROKEN
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
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