Suction Toothbrushes
FDA Label NDC 53462-273

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 Toothbrushes (NDC 53462-273). 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 toothbrushes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

 Active Ingredient Purpose
Antiseptic Oral Rinse
.05% Cetylpyridinium chlorideOral Antiseptic

Uses

  • Helps reduce the chance of infection in minor oral irritation.
  • Aids in the removal of debris, dental plaque 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 antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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 one minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other toothbrush as needed.
  • 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 should be supervised in the use of this product.
  • 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, sorbitol, peppermint flavor, potssium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1.

Questions

Call toll free 800-323-2220

Suction Toothbrushes

Suction Toothbrushes 6173 (Sus 6173 R5134f Bag)

Suction Toothbrushes 6173 (Sus 6173 R5134f Bag)

Antispetic Oral Rinse

Antiseptic Oral Rinse Packet (Sss 6173 R5267c Aorpacket)

Antiseptic Oral Rinse Packet (Sss 6173 R5267c Aorpacket)

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