NDC 71223-002 Amosan Wound Cleanser Cherry Flavour

Sodium Perborate Monohydrate

NDC Product Code 71223-002

NDC 71223-002-12

Package Description: 12 PACKET in 1 CARTON > 1.7 g in 1 PACKET

NDC Product Information

Amosan Wound Cleanser Cherry Flavour with NDC 71223-002 is a a human over the counter drug product labeled by Vintage Brands Limited. The generic name of Amosan Wound Cleanser Cherry Flavour is sodium perborate monohydrate. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Vintage Brands Limited

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Amosan Wound Cleanser Cherry Flavour Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM PERBORATE MONOHYDRATE 1.2 g/1.7g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TARTARIC ACID (UNII: W4888I119H)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vintage Brands Limited
Labeler Code: 71223
FDA Application Number: part356 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Amosan Wound Cleanser Cherry Flavour Product Label Images

Amosan Wound Cleanser Cherry Flavour Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Envelope)

Sodium perborate monohydrate 1.2g

Purpose

Oral Debriding Agent/Oral Wound Cleanser

Uses

  • Aids in the removal of phlegm, mucus, or other secretions with occasional sore mouthfor 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 gumsfor temporary use to cleanse canker soresassist in the removal of foreign material from minor wounds

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 daysirritation, pain, or redness persists or worsensswelling, rash, or faver develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm wateruse immediatelyswish solution around in the mouth over the affected area on gargle for at least 1 minute and then spit it out do not swallowuse up to 4 times daily after meals and at bedtime or as directed by a dentist or doctorchildren under 12 years of age should be supervised in the use of this productconsult a dentist or doctor for use in children under 6 years of age

Other Information

Do not store above 77°F (25°C)

Inactive Ingredients

L-tartaric acid, sodium saccharin, cherry flavor'

* Please review the disclaimer below.