Amosan Oral Wound Cleanser Mint Powder, For Solution
FDA Label NDC 71223-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vintage Brands Limited for the product Amosan Oral Wound Cleanser Mint (NDC 71223-001). 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 (in each envelope), purpose, uses, warnings, do not use, stop use and ask a doctor if, 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 (In Each Envelope)

Sodium perborate monohydrate 1.2g

Purpose

Oral Debriding Agent/Oral Wound Cleanser

Uses

  • aids in the removal of phlegm, 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, accidental injury, or other irritations of the mouth and gums
  • for temporary use to cleanse canker sores
  • assist in the removal of foreign material from minor wounds

Warnings

For external use only.

Do Not Use

  • for more than 7 days unless directed by a dentist or doctor.

Stop Use And Ask A Doctor If

  • sore mouth symptoms do not improve in 7 days.
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm water
  • use immediately.
  • swish solution around in the mouth over the affected area or gargle for at least 1 minute and then spit it out.
  • do not swallow.
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
  • children under 12 years of age should be supervised in the use of this product.
  • consult a dentist or doctor for use in children under 6 years of age.

Other Information

do not store above 77°F (25°C).

Inactive Ingredients

ginger essential oil, L-tartaric acid, menthol, peppermint essential oil, sodium saccharin, vanilla flavor.

Questions Or Comments

Visit AmosanOralProducts.com or call 1-800-707-9624.

Package Labeling:

Updated (Updatedlabel)

Updated (Updatedlabel)

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