SYSTANE ULTRA SINGLE VIALS- polyethylene glycol and propylene glycol solution/ drops

Systane Ultra Single Vials by

Drug Labeling and Warnings

Systane Ultra Single Vials by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Polyethylene glycol 400 0.4%..............................Lubricant

Propylene glycol 0.3%.........................................Lubricant

PURPOSE

Use

• for the temporary relief of burning and irritation due to dryness of the eye

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

WHEN USING

When using this product

• do not touch tip of container to any surface to avoid contamination
• do not reuse
• once opened, discard

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or last more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.

STORAGE AND HANDLING

Other information

• store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

aminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium hydroxide, sorbitol, water for injection

DOSAGE & ADMINISTRATION

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SYSTANE ULTRA SINGLE VIALS 
polyethylene glycol and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-843
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOLS - UNII:3WJQ0SDW1A)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%) (UNII: 6OX6A5C7B6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-843-04	0.4 mL in 1 VIAL; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/02/2017

Labeler - United Exchange Corp. (840130579)