Suction Swab System With Perox-a-mint Solution - Suction Swab And Suction Toothbrush
FDA Label NDC 53462-553

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 Swab System With Perox-a-mint Solution - Suction Swab And Suction Toothbrush (NDC 53462-553). 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 swab system with perox-a-mint solution - suction swab, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

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

Uses

Suction Swab

  • Aids in the removal of debris and secretions.
  • Suction Swab and Suction Toothbrush

    • 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 Swab

  • Use as directed on individual packages
  • Apply Mouth Moisturizer as needed.
  • Discard after use.
  • Suction Swabs and Applicator Swabs are intended for single oral use only.
  • 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 Swab and Suction Toothbrush

    • Use as directed on individual packages
    • Apply Mouth Moisturizer as needed.
    • Discard after use.
    • Suction Toothbrushes, Suction Swabs and Applicator Swabs are intended for single oral use only.
    • 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.

Suction Swab System With Perox-A-Mint Solution - Suction Swab

Suction Swab System 6550 (Sss 6550 R4560e Bag)

Suction Swab System 6550 (Sss 6550 R4560e Bag)

Suction Swab 6512 (Sus 6512 R5216e Drugfacts)

Suction Swab 6512 (Sus 6512 R5216e Drugfacts)

Suction Swab System With Perox-A-Mint Solution - Suction Swab And Suction Toothbrush

Suction Swab System 6552 (Sss 6552 R4558e Bag)

Suction Swab System 6552 (Sss 6552 R4558e Bag)

Suction Toothbrush 6571 (Sus 6571 R5130h Drugfacts)

Suction Toothbrush 6571 (Sus 6571 R5130h Drugfacts)

* Please review the disclaimer below.