Perox-a-mint Solution Mouthwash
FDA Label NDC 53462-075

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 Perox-a-mint Solution (NDC 53462-075). 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 active ingredient, purpose, use, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Use

Aids in the removal of secretions associated with sore mouth

Otc - Do Not Use

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid swallowing.

Otc - Stop Use

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 of 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

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 years of age:  supervise use.
  • Children under 3 years of age:  consult a dentist or doctor.

Inactive Ingredients

Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)

Otc - Questions

Questions? Call toll free 800-323-2220

Perox-A-Mint Solution

Perox-a-mint Bottle (44 mL) (R3674j 6065 Bottle)

Perox-a-mint Bottle (44 mL) (R3674j 6065 Bottle)

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