Amosan Oral Wound Cleanser

Amosan Oral Wound Cleanser

Drug Labeling and Warnings

Drug Details

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AMOSAN ORAL WOUND CLEANSER- sodium perborate monohydrate powder, for solution 
Vintage Brands Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amosan Oral Wound Cleanser

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

ginger essential oil, L-tartaric acid, menthol, peppermint essential oil, sodium saccharin, vanilla flavor.

Questions or Comments

Visit AmosanOralProducts.com or call 1-800-707-9624.

Package Labeling:

Inner Label

Box

AMOSAN ORAL WOUND CLEANSER 
sodium perborate monohydrate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71223-001
Route of AdministrationTOPICAL
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)  
MENTHOL (UNII: L7T10EIP3A)  
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 not finalpart35612/01/2017
Labeler - Vintage Brands Limited (248592383)

Revised: 11/2018
 
Vintage Brands Limited


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