NDC 53462-572 Suction Toothbrush With Perox-a-mint Solution

NDC Product Code 53462-572

NDC 53462-572-60

Package Description: 1 KIT in 1 KIT * 1 PACKET in 1 KIT > 7 mL in 1 PACKET (53462-075-60) * 2 g in 1 PACKET

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Suction Toothbrush With Perox-a-mint Solution with NDC 53462-572 is a product labeled by Sage Products, Llc. The generic name of Suction Toothbrush With Perox-a-mint Solution is . The product's dosage form is and is administered via form.

Labeler Name: Sage Products, Llc

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)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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
Start Marketing Date: 06-30-2003 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Suction Toothbrush With Perox-a-mint Solution Product Label Images

Suction Toothbrush With 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.