TOPCARE ULTRA LUBRICANT- polyethylene glycol 400, and propylene glycol solution/ drops 
Topco Associates LLC

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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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 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
  • replace cap after each use

Stop use and ask a doctor if

  • you fell 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

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

Other information

  • Store at room temperature.

Inactive ingredients

boric acid, calcium chloride, chlorhexidine gluconate (20%), hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO UNX416

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

MADE IN KOREA

image description

TOPCARE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-680
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
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYPROMELLOSE 2910 (15000 MPA.S) (UNII: 288VBX44JC)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-680-151 in 1 BOX09/30/2016
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/201602/28/2021
Labeler - Topco Associates LLC (006935977)

Revised: 4/2021
Document Id: c084739e-06dd-f2ea-e053-2a95a90a84c6
Set id: bca0b579-e133-45c9-a221-8f509961d707
Version: 2
Effective Time: 20210421
 
Topco Associates LLC