Oral B Mouth Sore Special Care Rinse
Sodium Fluoride
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 37000-962Oral B Mouth Sore Special Care Rinse also known as Sodium Fluoride is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Oral B Mouth Sore Special Care Rinse is 37000-962. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Oral B Mouth Sore Special Care Rinse drug includes Hydrogen Peroxide - .03 mL/20mL . The currest status of Oral B Mouth Sore Special Care Rinse drug is Active.
Drug Information:
| Drug NDC: | 37000-962 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Oral B Mouth Sore Special Care Rinse |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Oral B Mouth Sore |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Special Care Rinse |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Procter & Gamble Manufacturing Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROGEN PEROXIDE - .03 mL/20mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 02 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | The Procter & Gamble Manufacturing Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | BBX060AN9V
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 37000-962-08 | 237 mL in 1 BOTTLE, PLASTIC (37000-962-08) | 02 Jan, 2020 | N/A | No |
| 37000-962-16 | 475 mL in 1 BOTTLE, PLASTIC (37000-962-16) | 02 Jan, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose oral debriding/wound cleansing
Product Elements:
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
Indications and Usage:
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.
Warnings:
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.
Dosage and Administration:
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
Package Label Principal Display Panel:
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
Further Questions:
Questions? 1-800-862-7442