NDC 0404-0012 Henry Schein Mouth

1.5% Hydrogen Peroxide

NDC Product Code 0404-0012

NDC 0404-0012-01

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Henry Schein Mouth with NDC 0404-0012 is a a human over the counter drug product labeled by Henry Schein Inc.. The generic name of Henry Schein Mouth is 1.5% hydrogen peroxide. The product's dosage form is rinse and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 358975.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Henry Schein Mouth 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.


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.

  • SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • MENTHOL (UNII: L7T10EIP3A)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Henry Schein Inc.
Labeler Code: 0404
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: 06-30-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Henry Schein Mouth Product Label Images

Henry Schein Mouth 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

Hydrogen peroxide 1.5% (w/w)

Purpose(S)

Oral debriding agent/oral wound cleanser

Uses

  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

Otc - Do Not Use

Do not use this product for more than 7 days unless directed by your dentist or physician.

Otc - When Using

When using this product, do not swallow.

Otc - Stop Use

  • Stop use and ask your doctor if:Sore mouth symptoms do not improve within 7 daysIrritation, pain, or redness persists or worsensSwelling, rash, or fever develops

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.Children under 2 years of age: consult a dentist or physician.Children under 12 years of age should be supervised in the use of the product.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For adults and children 2 years of age or older: rinse 10mL around in the mouth over the affected area for at least 1 minute, than split out.Use up to 4 times daily after meals and at bed time, or as directed by a dentist or physician.

Other Information

  • Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.For your protection, do not use if tamper evident seal under the cap is damaged or missing.

Inactive Ingredients

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

* Please review the disclaimer below.