FDA Label for Amosan Oral Wound Cleanser Spearmint

View Indications, Usage & Precautions

Amosan Oral Wound Cleanser Spearmint Product Label

The following document was submitted to the FDA by the labeler of this product Vintage Brands Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




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 effected area or gargle for 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



L-tartaric acid, sodium saccharin, peppermint flavor


Questions Or Comments



Visit AmosanOralProducts.com or call 1-877-450-6436.


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