OXISTOM- oral wound cleanser liquid PRO-SYS- oral wound cleanser liquid

PRO-SYS by

Drug Labeling and Warnings

PRO-SYS by is a Otc medication manufactured, distributed, or labeled by Forward Science Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol

Questions?

1-855-696-7254

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral Debriding Agent / Oral Wound Cleanser

Other Information

Store at controlled room temperatures 68 - 77ºF (20 - 25ºC) and away from direct sunlight. Keep cap tightly closed when not in use.

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.
Assists in the removal of foreign material from minor oral wounds.

Warnings

Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow.
Stop use and ask a dentist or physician 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 more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
Children under 12 years of age should be supervised in the use of the product.
Children under 2 years of age: Consult a dentist or physician.

Directions

Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out.
Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician.
Children under 12 years of age should be supervised in the use of the product.
Children under 2 years of age: Consult a dentist or physician.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXISTOM 
oral wound cleanser liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70275-937
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70275-937-13	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/26/2021

PRO-SYS 
oral wound cleanser liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70275-201
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70275-201-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2022
2	NDC: 70275-201-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/16/2022

Labeler - Forward Science Technologies LLC (079212068)

Establishment
Name	Address	ID/FEI	Business Operations
Forward Science Technologies LLC		079212068	manufacture(70275-937, 70275-201)