SYSTANE ULTRA SINGLE VIALS- polyethylene glycol and propylene glycol solution/ drops 
United Exchange Corp.

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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Systane Ultra Single Eye Drops 0.4 ml 16843ZZ (2018)

Active ingredients Purpose

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

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

Use

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

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

Made in South Korea

single

SYSTANE ULTRA SINGLE VIALS 
polyethylene glycol and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-843
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOLS - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-843-040.4 mL in 1 VIAL; Type 0: Not a Combination Product01/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/02/2017
Labeler - United Exchange Corp. (840130579)

Revised: 1/2018
Document Id: 638a4320-9c1b-4122-e053-2991aa0af758
Set id: 638a4320-9c1a-4122-e053-2991aa0af758
Version: 1
Effective Time: 20180124
 
United Exchange Corp.