NDC 0126-0083 Peroxyl Mouth Sore Mild Mint

Hydrogen Peroxide

NDC Product Code 0126-0083

NDC 0126-0083-16

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 0126-0083-70

Package Description: 50 POUCH in 1 CARTON > 10 mL in 1 POUCH

NDC 0126-0083-99

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Peroxyl Mouth Sore Mild Mint with NDC 0126-0083 is a a human over the counter drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Peroxyl Mouth Sore Mild Mint is hydrogen peroxide. The product's dosage form is rinse and is administered via buccal form.

Labeler Name: Colgate Oral Pharmaceuticals, Inc.

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.

Peroxyl Mouth Sore Mild Mint 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.

  • HYDROGEN PEROXIDE 15 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLOXAMER 338 (UNII: F75JV2T505)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

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

  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Buccal - Administration directed toward the cheek, generally from within 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: Colgate Oral Pharmaceuticals, Inc.
Labeler Code: 0126
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: 01-01-2009 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.

Peroxyl Mouth Sore Mild Mint Product Label Images

Peroxyl Mouth Sore Mild Mint 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

Other

Drug Facts

Dist. by:COLGATE-PALMOLIVE COMPANYNew York, NY 10022

Active Ingredient

Hydrogen peroxide 1.5% (w/v)

Purposes

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 a dentist or physician.

Otc - When Using

When using this product, do not swallow.

Stop Use And Ask A 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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit outUse up to 4 times daily after meals and at bedtime or as directed by a dentist or physicianChildren under 12 years of age should be supervised in the use of the productChildren under 2 years of age: consult a dentist or physician

Inactive Ingredients

Water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, FD&C blue no. 1

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

1-800-468-6502

* Please review the disclaimer below.