Label: AMOSAN ORAL WOUND CLEANSER- sodium perborate monohydrate powder, for solution

  • NDC Code(s): 71223-001-12
  • Packager: Vintage Brands Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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 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:

    Label0

  • INGREDIENTS AND APPEARANCE
    AMOSAN ORAL WOUND CLEANSER 
    sodium perborate monohydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71223-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PERBORATE MONOHYDRATE (UNII: Y9UKD0XE6F) (BORATE ION - UNII:44OAE30D22) BORATE ION1.2 g  in 1.7 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71223-001-1212 in 1 CARTON12/01/2017
    11.7 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/01/2017
    Labeler - Vintage Brands Limited (248592383)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!