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TopCare Ultra Lubricant

Medically reviewed on September 30, 2016

Dosage form: solution/ drops
Ingredients: POLYETHYLENE GLYCOL 400 4mg in 1mL, PROPYLENE GLYCOL 3mg in 1mL
Labeler: Topco Associates LLC
NDC Code: 36800-680

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.

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

TOPCARE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-680
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
CALCIUM CHLORIDE 
CHLORHEXIDINE GLUCONATE 
HYDROCHLORIC ACID 
HYPROMELLOSE 2910 (15000 MPA.S) 
MAGNESIUM CHLORIDE 
POTASSIUM CHLORIDE 
WATER 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
ZINC CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:36800-680-151 BOTTLE, DROPPER in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/2016
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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