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| Product NDC Code | 83062-086 | ||||
|---|---|---|---|---|---|
| Drug Name | Medline peroxi fresh mouthwash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 358975, 1038750 |
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| Application Number | M022 | ||||
| Labeler Name | IIMED MEDICAL MEXICANA S DE RL DE CV | ||||
| Packages |
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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 or over: swish around in mouth over affected afrea for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor. -Children under 12 years of age: Should be supervised in the use of this product. -Children under 2 years of age: Consult a dentist or a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavor, sodium lauryl sulfate, sodium saccharin, water
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.Use Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
Purpose
Information about the drug product’s indications for use.Purpose Oral debriding agent
Spl product data elements
Usually a list of ingredients in a drug product.Medline Peroxi Fresh Mouthwash Hydrogen peroxide mouthwash SODIUM LAURYL SULFATE WATER SACCHARIN SODIUM HYDROGEN PEROXIDE HYDROGEN PEROXIDE
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.Label Entire Label
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 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 If more than used for rinsing is accidentally swallowed, get medical hep or contact Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Avoid excessive heat and protect from freezing.
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 in 7 days -irritation, pain or redness persists or worsens -swelling, rash or fever develops
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
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 Do not use for more than 7 days unless directed by a dentist or physician When using this product Do not swallow Stop use and ask a doctor if -sore mouth symptoms do not improve in 7 days -irritation, pain or redness persists or worsens -swelling, rash or fever develops Keep out of reach of children if If more than used for rinsing is accidentally swallowed, get medical hep or contact Poison Control Center right away
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