Topcare Health Artificial Tears: Package Insert and Label Information

TOPCARE HEALTH ARTIFICIAL TEARS- povidone and polyvinyl alcohol, unspecified solution
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.

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Polyvinyl alcohol………………….Eye lubricant

Povidone……………………………Eye lubricant

Uses

  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irrittions of the eye, or to exposure to wind or sun

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or perists for more than 72 hours

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed
  • remove contact lens before using

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

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

Other information

  • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15º-30ºC (59º-86ºF)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

 carton
(click image for full-size original)

TOPCARE HEALTH ARTIFICIAL TEARS
polyvinyl alcohol, povidone solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-972
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE (POVIDONE) POVIDONE 0.6 g in 100 mL
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL, UNSPECIFIED) POLYVINYL ALCOHOL, UNSPECIFIED 0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE
SODIUM PHOSPHATE, MONOBASIC
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM CHLORIDE
WATER
SODIUM CITRATE
EDETATE DISODIUM (EDETIC ACID)
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-972-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (36800-972-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/31/2020
Labeler — Topco Associates LLC (006935977)
Registrant — K.C. Pharmaceuticals, Inc. (174450460)
Establishment
Name Address ID/FEI Operations
K.C. Pharmaceuticals, Inc. 174450460 manufacture (36800-972), pack (36800-972), label (36800-972)

Revised: 02/2020 Topco Associates LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.