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| Product NDC Code | 0126-0083 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Peroxyl mouth sore mild mint |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | BUCCAL | ||||||||||||
| Dosage Form | RINSE | ||||||||||||
| RxCUI drug identifier | 358975, 1727009 |
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| Application Number | M022 | ||||||||||||
| Labeler Name | Colgate Oral Pharmaceuticals, 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% (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 half a capful (two teaspoons or 10 mL) around in the mouth over affected area 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 physician Children under 12 years of age should be supervised in the use of the product Children under 2 years of age: consult a dentist or physician
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, FD&C blue no. 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 for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums
Purpose
Information about the drug product’s indications for use.Purposes Oral debriding agent/oral wound cleanser
Spl product data elements
Usually a list of ingredients in a drug product.Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE WATER SORBITOL PROPYLENE GLYCOL POLOXAMER 338 POLYSORBATE 20 SACCHARIN SODIUM FD&C BLUE NO. 1 Light Blue Solution with the Smell of Mint
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 - 500 mL Bottle Label ALCOHOL FREE* Colgate ® Oral Debriding Agent Peroxyl ® Mouth Sore Rinse | 1.5% Hydrogen Peroxide CLEANSES & PROMOTES HEALING OF MINOR ORAL WOUNDS HELPS PROMOTE HEALING OF: ✓ ORAL SORES ✓ IRRITATIONS ✓ MOUTH BURNS MILD MINT 16.9 FL OZ (1.05 PT) 500 mL Helps Promote Healing P9933376 PRINCIPAL DISPLAY PANEL - 500 mL Bottle 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
Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022
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 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? 1-800-468-6502
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
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 Do not use this product 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 within 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops 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.
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