Sore Mouth Cleanser

Hydrogen Peroxide


Rite Aid
Human Otc Drug
NDC 11822-1462
Sore Mouth Cleanser also known as Hydrogen Peroxide is a human otc drug labeled by 'Rite Aid'. National Drug Code (NDC) number for Sore Mouth Cleanser is 11822-1462. This drug is available in dosage form of Mouthwash. The names of the active, medicinal ingredients in Sore Mouth Cleanser drug includes Hydrogen Peroxide - 1588 mg/mL . The currest status of Sore Mouth Cleanser drug is Active.

Drug Information:

Drug NDC: 11822-1462
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: Sore Mouth Cleanser
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Hydrogen Peroxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Rite Aid
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Mouthwash
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 - 1588 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
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: 03 Feb, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
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: part333A
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:Rite Aid
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
11822-1462-3236 mL in 1 BOTTLE, PLASTIC (11822-1462-3)03 Feb, 2012N/ANo
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 agent/oral wound cleanser

Product Elements:

Sore mouth cleanser hydrogen peroxide hydrogen peroxide hydrogen peroxide water sorbitol propylene glycol poloxamer 338 polysorbate 20 saccharin sodium fd&c blue no. 1

Indications and Usage:

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

Warnings:

Warnings for this product

Do Not Use:

Warnings for this product

When Using:

When using this product do not swallow

Dosage and Administration:

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 physician children under 12 should be supervised in the use of the product children under 2 years of age: consult a dentist or doctor

Adverse Reactions:

Adverse reactions satisfaction guarantee: if you're not satisfied we'll happily refund your money. distributed by: rite aid 30 hunter lane camp hill, pa 17011 www.riteaid.com

Package Label Principal Display Panel:

Principal display panel sealed with printed neckband for your protection compare to colgate peroxy mouth sore rinse alcohol-free mild mint free from alcohol free peroxide mouth rinse hydrogen peroxide oral debriding agent mint 1.5% hydrogen peroxide cleans and helps relieve minor irritations 8 fl oz (236 ml) image description


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.