NDC 53462-075 Perox-a-mint Solution

Hydrogen Peroxide

NDC Product Code 53462-075

NDC 53462-075-30

Package Description: 44 mL in 1 BOTTLE, PLASTIC

NDC 53462-075-60

Package Description: 7 mL in 1 PACKET

NDC Product Information

Perox-a-mint Solution with NDC 53462-075 is a a human over the counter drug product labeled by Sage Products, Llc. The generic name of Perox-a-mint Solution is hydrogen peroxide. The product's dosage form is mouthwash and is administered via buccal form.

Labeler Name: Sage Products, Llc

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Perox-a-mint Solution 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

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.

Product Labeler Information

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

Labeler Name: Sage Products, Llc
Labeler Code: 53462
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: 05-21-1998 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: 12-31-2021 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’.

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Perox-a-mint Solution Product Label Images

Perox-a-mint Solution 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

Drug Facts

Active Ingredients Purpose Perox-A-Mint Solution Hydrogen peroxide 1.5% Oral Debriding Agent

Uses

  • Aids in the removal of dental plaque, debris and secretions.

Warnings

  • Stop use and ask a doctor if:Sore mouth symptoms do not improve in 7 days.Swelling, rash or fever develops.Irritation, pain or redness persists or worsens.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Suction Toothbrush with Perox-A-Mint Solution and Mouth MoisturizerBefore opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.Remove toothbrush and attach to suction line.Clean teeth and oral cavity for approximately 1 minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate solution.Discard after use.Use Applicator Swab to apply Mouth Moisturizer as needed.Use up to 4 times daily, or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Questions

Call toll-free 800-323-2220

* Please review the disclaimer below.