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

Amosan Oral Wound Cleanser by

Drug Labeling and Warnings

Amosan Oral Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Vintage Brands Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

AMOSAN ORAL WOUND CLEANSER 
sodium perborate monohydrate powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71223-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PERBORATE MONOHYDRATE (UNII: Y9UKD0XE6F) (BORATE ION - UNII:44OAE30D22)	BORATE ION	1.2 g  in 1.7 g

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71223-001-12	12 in 1 CARTON	12/01/2017
1		1.7 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2017

Labeler - Vintage Brands Limited (248592383)