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| Product NDC Code | 41250-750 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sore mouth cleanser |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | MOUTHWASH | ||||||
| RxCUI drug identifier | 358975 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Meijer | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Hydrogen peroxide 1.5% w/v
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: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or pysician children under 12 should be supervised in the use of the 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 water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1
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 removal of phlgem, mucus, or other secretions associated with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums for temporary use to cleanse canker sores assists in the removal of foreign material from minor oral wounds
Purpose
Information about the drug product’s indications for use.Purpose Oral debriding agent/Oral wound cleanser
Spl product data elements
Usually a list of ingredients in a drug product.Sore Mouth Cleanser Hydrogen Peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE WATER SORBITOL PROPYLENE GLYCOL POLOXAMER 338 POLYSORBATE 20 SACCHARIN SODIUM FD&C BLUE NO. 1
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.Principal display panel NDC 41250-750-77 meijer *COMPARE TO COLGATE PEROXYL ® MOUTH SORE RINSE ACTIVE INGREDIENT* ALCOHOL FREE Sore Mouth Peroxide Rinse ORAL DEBRIDING AGENT HYGROGEN PEROXIDE SOOTHING MINT Cleans and helps relieve minor mouth and gum irritation 16.9 FL OZ (1.05 PT) 500 mL image description
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.Disclaimer *This product is not manufactured or distributed by Colgate-Palmolive Company, distributor of Colgate ® Peroxyl ® Mouth Sore Rinse.
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 doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-593-0593
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 store at controlled room temperature 68-77°F (20-25°C)
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 For this product
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