FAMILY CARE SINGLE-USE EYE- polyethylene glycol 400, 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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Family Care Single Use Lubricant Eye Drops 30ct NBE Systane (584)

Active ingredients                                       Purpose

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

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

Uses

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

Warnings

For external use only.

Do not use

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

When using this product

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

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 lasts more than 72 hours

Keep out of reach of children.

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

Directions

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

Other information

  • Store at room temperature

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

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 U.S.A.

www.ueccorp.com

Toll Free: 1 800 814 8028

Made in Korea

image description

FAMILY CARE SINGLE-USE EYE 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-584
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BORIC ACID (UNII: R57ZHV85D4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-584-2530 in 1 BOX03/28/2016
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/28/201611/10/2021
Labeler - United Exchange Corp. (840130579)

Revised: 11/2021
 
United Exchange Corp.