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

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sage Products, Llc for the product Suction Toothbrush With Perox-a-mint Solution (NDC 53462-572). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, questions, suction toothbrush with perox-a-mint, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 Moisturizer

  • Before 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

Suction Toothbrush With Perox-A-Mint

Single Use System 6572 (Sus 6572 R5213e Drugfacts)

Single Use System 6572 (Sus 6572 R5213e Drugfacts)

Perox-A-Mint

Perox-a-mint (Peroxamint Packet)

Perox-a-mint (Peroxamint Packet)

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