FDA.reportPublic FDA data

Amosan Wound Cleanser

Manufacturer
Vintage Brands Limited
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:38:06

Label at a glance#

ProductAmosan Oral Wound Cleanser Cherry
Active ingredientSODIUM PERBORATE MONOHYDRATE
Label structure8 sections

Indications and uses

aids in the removal of phlegm, mucus, or other secretions 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

Dosage and administration

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 on 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 prod...

Label contents#

Full prescribing information#

Active ingredient (in each envelope)

OTC - ACTIVE INGREDIENT SECTION

Sodium perborate monohydrate 1.2g

Purpose

OTC - PURPOSE SECTION

Oral Debriding Agent/Oral Wound Cleanser

Uses

INDICATIONS & USAGE SECTION

  • aids in the removal of phlegm, mucus, or other secretions 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 on 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

SPL UNCLASSIFIED SECTION

do not store above 77°F (25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

L-tartaric acid, sodium saccharin, cherry flavor'

Questions or Comments

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71223-002-12Amosan Oral Wound Cleanser Cherry1.7 g in 1 PACKETPOWDER, FOR SOLUTION1.75
71223-002-12Amosan Oral Wound Cleanser Cherry12 in 1 CARTONPOWDER, FOR SOLUTION125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71223-002AMOSAN ORAL WOUND CLEANSER CHERRY (SODIUM PERBORATE MONOHYDRATE) POWDER, FOR SOLUTION [VINTAGE BRANDS LIMITED]5Current NDC, Legacy NDC, 2 package rows20241121_a0e145c8-6b08-40be-ae4f-5678c4a78b1e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71223-00271223-002-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PERBORATE MONOHYDRATEY9UKD0XE6FACTIM

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
ndc (package): 71223-002-12
ndc (product): 71223-002
ndc11 (package): 71223000212
spl id: 25b27d6e-f933-646b-e063-6294a90a0daa
spl set id: a0e145c8-6b08-40be-ae4f-5678c4a78b1e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.