topcare health lubricant eye drops (pld)

topcare health lubricant eye drops (pld)
SPL v4
SPL
SPL Set ID e8e9dfe5-3540-a4df-e053-2a95a90aaf98
Route
ophthalmic
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carboxymethylcellulose (0.5 g)
Inactive Ingredients
potassium chloride sodium lactate calcium chloride hydrochloric acid sodium hydroxide sodium chloride magnesium chloride water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-17

Purpose

Lubricant

Description

Carboxymethylcellulose sodium 0.5%


Medication Information

Warnings

For external use only

Uses
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
  • may be used as a protectant against further irritation
Purpose

Lubricant

Directions
  • to open, twist and pull tab to remove
  • instill 1 or 2 drops in the affected eye(s) as needed and discard container
  • if used post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions
Other Information
  • store at 15°-25° C (59°-77° F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
Inactive Ingredients

calcium chloride. **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate.

**May contain these ingredients to adjust pH.

Description

Carboxymethylcellulose sodium 0.5%

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Questions Or Comments?

Call 1-888-423-0139

When Using This Product
  • do not reuse
  • once opened, discard
  • to avoid contamination, do not touch tip of container to any surface
  • do not touch unit-dose tip to eye
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 occur
  • redness or irritation of the eye continues
  • redness or irritation of the eye worsens or persists for more than 72 hours
Keep Out of the Reach of Children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Topcare Health Lubricant Eye Drops 30ct


Structured Label Content

Warnings

For external use only

Uses
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
  • may be used as a protectant against further irritation
Purpose

Lubricant

Directions
  • to open, twist and pull tab to remove
  • instill 1 or 2 drops in the affected eye(s) as needed and discard container
  • if used post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions
Other Information (Other information)
  • store at 15°-25° C (59°-77° F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
Inactive Ingredients (Inactive ingredients)

calcium chloride. **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate.

**May contain these ingredients to adjust pH.

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Questions Or Comments? (Questions or comments?)

Call 1-888-423-0139

When Using This Product (When using this product)
  • do not reuse
  • once opened, discard
  • to avoid contamination, do not touch tip of container to any surface
  • do not touch unit-dose tip to eye
Do Not Use This Product If (Do not use this product if)
  • solution changes color or becomes cloudy
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye continues
  • redness or irritation of the eye worsens or persists for more than 72 hours
Keep Out of the Reach of Children. (Keep out of the reach of children.)

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Topcare Health Lubricant Eye Drops 30ct (TopCare Health Lubricant Eye Drops 30ct)


Advanced Ingredient Data


Raw Label Data

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