Amosan Wound Cleanser Cherry Flavour
Sodium Perborate Monohydrate
Vintage Brands Limited
Human Otc Drug
NDC 71223-002Amosan Wound Cleanser Cherry Flavour also known as Sodium Perborate Monohydrate is a human otc drug labeled by 'Vintage Brands Limited'. National Drug Code (NDC) number for Amosan Wound Cleanser Cherry Flavour is 71223-002. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Amosan Wound Cleanser Cherry Flavour drug includes Sodium Perborate Monohydrate - 1.2 g/1.7g . The currest status of Amosan Wound Cleanser Cherry Flavour drug is Active.
Drug Information:
| Drug NDC: | 71223-002 |
| 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: | Amosan Wound Cleanser Cherry Flavour |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Amosan Wound Cleanser |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Cherry Flavour |
| 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 Perborate Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vintage Brands Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For Solution |
| 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: | SODIUM PERBORATE MONOHYDRATE - 1.2 g/1.7g
|
| 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: | 01 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 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: | Vintage Brands Limited
|
| 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. |
| UPC: | 0818273020089
|
| UPC stands for Universal Product Code. |
| UNII: | Y9UKD0XE6F
|
| 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 |
|---|
| 71223-002-12 | 12 PACKET in 1 CARTON (71223-002-12) / 1.7 g in 1 PACKET | 01 Jun, 2019 | 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 agent/oral wound cleanser
Product Elements:
Amosan wound cleanser cherry flavour sodium perborate monohydrate tartaric acid saccharin sodium sodium perborate monohydrate borate ion
Indications and Usage:
Uses aids in the removal of phlegm, mucus, or other secretions with occasional sore mouth for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury,or other irritations of the mouth and gums for temporary use to cleanse canker sores assist in the removal of foreign material from minor wounds
Warnings:
Warnings for external use only. do not use for more than 7 days unless directed by a dentist or doctor stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or faver develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only. do not use for more than 7 days unless directed by a dentist or doctor stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or faver develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm water use immediately swish solution around in the mouth over the affected area on gargle for at least 1 minute and then spit it out do not swallow use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product consult a dentist or doctor for use in children under 6 years of age
Stop Use:
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or faver develops
Package Label Principal Display Panel:
Package labeling: label
Further Questions:
Questions or comments visit amosanoralproducts.com or call 1-877-450-6436.