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| Product NDC Code | 69951-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Prevention mouth rinse |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 358975 | ||||
| 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 ingredient Hydrogen peroxide 1.5%
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: swish one capful (10 ml) around in mouth over affected area for at least one minute and then spit out use up to 4 times daily, after meals and at bedtime or as directed by a dentist or doctor children under 12 should be supervised in the use of product. children under 2 years of age: consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients De-ionized water, glycerin, poloxamer 407, sodium lauryl sulfate, disodium EDTA, Mentha piperita (peppermint) oil, sodium citrate, sodium saccharin, citric acid, zinc chloride, menthol
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 first aid to help reduce the risk of infection in minor cuts and scrapes caused by dentures dental procedures orthodontic appliances accidental injury aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth for temporary use to cleanse canker sores, minor wounds and gum irritation
Purpose
Information about the drug product’s indications for use.Purpose Oral debriding agent / Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Prevention Mouth Rinse Hydrogen peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE CITRIC ACID MONOHYDRATE WATER EDETATE DISODIUM GLYCERIN MENTHOL PEPPERMINT OIL POLOXAMER 407 SODIUM CITRATE ZINC CHLORIDE SODIUM LAURYL SULFATE SACCHARIN SODIUM SACCHARIN
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 MOUTH SORE RELIEF Oral Antiseptic for Healing of Common Mouth Sores CANKER SORES IRRITATION FROM BRACES MINOR MOUTH INJURIES 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 Distribured by: Prevention Health Sciences, Inc. Raleigh, IL 62977 800-473-1205 PHS Brands
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 for more than 7 days unless directed by a dentist or doctor
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 more than used for rinsing is accidentally 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 mouth symptoms do not improve within 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
Storage and handling
Information about safe storage and handling of the drug product.Other information keep away from heat or direct sunlight Do not use if safey seal under cap is broken or missing
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