Topco Associates LLC. Lubricant Eye Drops Drug Facts

Topcare Lubricant Eye by

Drug Labeling and Warnings

Topcare Lubricant Eye by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPCARE LUBRICANT EYE- polyethylene glycol, 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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Topco Associates LLC. Lubricant Eye Drops Drug Facts

Active ingredients (in each single-use container)

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purpose

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, persist 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 (1-800-222-1222).

Directions

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

Other information

  • store at 20-25°C (68-77°F)
  • protect from light

Inactive ingredients

boric acid, calcium chloride dihydrate, hypromellose, magnesium chloride hexahydrate, potassium chloride, sodium chloride, water for injection, zinc chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

PRESERVATIVE-FREE VIALS

Lubricant Eye Drops

POLYETHYLENE GLYCOL 0.4%

PROPYLENE GLYCOL 0.3%

Long lasting relief

Soothing comfort

Dry eye therapy

Actual Size

COMPARE TO Systane® active ingredients

30 SINGLE-USE CONTAINERS 0.01 FL OZ (0.4 mL) EACH STERILE

TopCare Lubricant Eye Drops image
TOPCARE LUBRICANT EYE 
polyethylene glycol, propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-896
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 36800-896-656 in 1 CARTON09/04/201302/01/2020
15 in 1 POUCH
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 finalpart34909/04/201302/01/2020
Labeler - Topco Associates LLC (006935977)

Revised: 12/2019
Document Id: c76c2100-3353-4566-9228-94b56cf494d4
Set id: 0cc92ee4-4cd5-4488-9f77-48921297d501
Version: 4
Effective Time: 20191216
 
Topco Associates LLC