Drug Facts
Drug Facts
Amosan Oral Wound Cleanser Mint Powder, For Solution
FDA Label NDC 71223-004
13 label sections · Submitted to the FDA by Vintage Brands Limited · 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 71223-004). 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, otc - active ingredient section, uses, purpose, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient Section
Sodium perborate monohydrate 1.2 g
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
Purpose
Oral Debriding Agent/Oral Wound Cleanser
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
L-tartaric acid, sodium saccharin, peppermint flavor
Questions Or Comments
Visit AmosanOralProducts.com or call 1-877-450-6436.
Package Labeling
Label (Amosan Oral Wound Cleanser Mint 18 Pack Under 1mb)
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