Sore Mouth Cleanser Mouthwash
FDA Label NDC 69842-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Sore Mouth Cleanser (NDC 69842-008). 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, uses, warnings, do not use, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrogen peroxide 150 mg/10mL

Purpose

Oral debriding agent/Oral wound cleanser

Uses

  • aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
  • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
  • for temporary use to cleanse canker sores
  • assists in the removal of foreign material from minor oral wounds

Warnings

For this product

Do Not Use

this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days: if irritation, pain, or redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When Using This Product

do not swallow

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

  • adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
  • children under 12 should be supervised in the use of the product
  • children under 2 years of age: consult a dentist or doctor

Other Information

store at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients

water, sorbitol, propylene glcol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1

Disclaimer

This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Alcohol-Free Mild Mint

Adverse Reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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Made in the U.S.A. with U.S. and Foreign Parts

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462.002/462AA rev 1

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Health

Compare to the active ingredient in Colgate Peroxyl Oral Cleanser

Alcohol Free

Peroxide Sore

Mouth Cleanser

HYDROGEN PEROXIDE 1.5%

  • Oral debriding agent
  • Oral antiseptic
  • Helps reduce bacteria to promote better oral health

    • Soothing Mint

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    8 FL OZ (236 mL)

    Image Description (Mm2)

    Image Description (Mm2)

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