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

  • NDC Code(s): 71223-003-00
  • Packager: Vintage Brands Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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  • 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.

  • Package Labeling:

    Outer Labelinner label

  • INGREDIENTS AND APPEARANCE
    AMOSAN ORAL WOUND CLEANSER SPEARMINT 
    sodium perborate monohydrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71223-003
    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:71223-003-0012 in 1 CARTON04/01/2024
    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 DrugM02204/01/2024
    Labeler - Vintage Brands Limited (248592383)
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