Suction Swabs With Perox-a-mint Solution
FDA Label NDC 53462-813

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 Swabs With Perox-a-mint Solution (NDC 53462-813). 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, otc - questions, suction swabs with perox-a-mint solution, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Suction Swab with Perox-A-Mint Solution
Active Ingredient: 
PEROX-A-MINT: 		Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent

Uses

  • Aids in the removal of 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 Swabs with Perox-A-Mint solution and Mouth Moisturizer

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Suction Swab and attach to suction line.
  • Clean teeth and oral cavity for approximately 1 minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other Suction Swab as needed.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard after use.
  • 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.

    • Suction Swabs with Perox-A-Mint solution

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Remove Suction Swab and attach to suction line.
    • Clean teeth and oral cavity for approximately 1 minute.
    • To suction, place thumb over port.
    • Repeat cleaning with other Suction Swab as needed.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard after use.
    • 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).

Otc - Questions

Questions? Call toll-free 800-323-2220.

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Perox-a-mint Solution (Peroxamint Packet)

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