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| Product NDC Code | 37000-962 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Oral b mouth sore special care rinse |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | RINSE | ||||||
| Application Number | M021 | ||||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||||
| 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 6 yrs. & older: Rinse with 20 mL Swish around in the mouth over the affected area for at least 1 minute and then spit out. Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor. do not swallow children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, flavor, glycerin, poloxamer 407, propylene glycol, sodium citrate, sodium hexametaphosphate, sodium saccharin, sucralose, 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.Uses For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. For temporary use to cleanse canker sores.
Purpose
Information about the drug product’s indications for use.Purpose oral debriding/wound cleansing
Spl product data elements
Usually a list of ingredients in a drug product.Oral B Mouth Sore Special Care Rinse Sodium Fluoride WATER GLYCERIN SODIUM CITRATE SACCHARIN SODIUM POLOXAMER 407 SUCRALOSE SODIUM POLYMETAPHOSPHATE PROPYLENE GLYCOL HYDROGEN PEROXIDE HYDROGEN PEROXIDE CITRIC ACID MONOHYDRATE
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 - 475 mL Bottle Label Oral-B HYDROGEN PEROXIDE ORAL DEBRIDING AGENT MOUTH SORE SPECIAL CARE ORAL RINSE For Mouth Sores Including: Canker Sores Cheek Bites Braces & Denture Irritations Oral & Gum Irritations SOOTHING MINT 475 mL (16 FL OZ) 962
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
DISTR. BY ORAL-B, A DIVISION OF PROCTER & GAMBLE, CINCINNATI, OH 45202
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? 1-800-862-7442
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 doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. 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