SPL v9
SPL
SPL Set ID e8b4df3b-3d81-b3ca-e053-2a95a90af2ec
Route
TOPICAL
Published
Effective Date 2022-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg)
Inactive Ingredients
Water Boric Acid Sodium Chlorite Calcium Chloride Magnesium Chloride Potassium Chloride Sodium Citrate Mannitol Glycerin Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-20

Description

Carboxymethyl cellulose sodium Eye Drops 0.5% w/v


Medication Information

Description

Carboxymethyl cellulose sodium Eye Drops 0.5% w/v

Use

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dose

Instill 1 or 2 drops in the affected eyes as needed

Carton

Warnings

For external use only

Questions

Call. 1-800-103-7321

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use

1.If you are sensitive to any ingredient in this product

2.If solution changes color or becomes cloudy

Eye Lubricant

Eye lubricant

Active Ingredient

Carboxymethyl cellulose sodium Eye Drops 0.5% w/v

Tamper Protection
  • For your protection a tamper evident ring is attached to the bottlecap
  • Upon opening, this will separate from the cap and can be discarded
  • Use only if this ring is present and attached when the bottle is first opened
Directions for Use
  • lnstill 1or 2 drops in the affected eye, as needed
Indication & Usage

Do not touch the nozzle tip to any surface since this may contaminate the solution

Remove contact lenses before use Should not use at the same time as other ophthalmic drugs

Replace cap after using

Inactive Ingredient

1.Boric acid

2.Calcium chloride

3.Glycerin

4.Magnesium chloride

5.Mannitol

6.Potassium chloride

7.Purified water

8.Stablized oxy cholro complex

9.Sodium tetra borate

10.Sodium hyaluronate

11.Sodium citrate

Stop Use and Ask A Doctor If

1.Excessive watering of the eye

2.Burning, stinging,foreign body sensation Continued redness (or) irritation of the eye, unusual eye secretions, change in vision

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away


Structured Label Content

Use

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dose

Instill 1 or 2 drops in the affected eyes as needed

Carton

Warnings

For external use only

Questions

Call. 1-800-103-7321

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use (Do not use)

1.If you are sensitive to any ingredient in this product

2.If solution changes color or becomes cloudy

Eye Lubricant (Eye lubricant)

Eye lubricant

Active Ingredient (Active ingredient)

Carboxymethyl cellulose sodium Eye Drops 0.5% w/v

Tamper Protection
  • For your protection a tamper evident ring is attached to the bottlecap
  • Upon opening, this will separate from the cap and can be discarded
  • Use only if this ring is present and attached when the bottle is first opened
Directions for Use (DIRECTIONS FOR USE)
  • lnstill 1or 2 drops in the affected eye, as needed
Indication & Usage (Indication & usage)

Do not touch the nozzle tip to any surface since this may contaminate the solution

Remove contact lenses before use Should not use at the same time as other ophthalmic drugs

Replace cap after using

Inactive Ingredient (INACTIVE INGREDIENT)

1.Boric acid

2.Calcium chloride

3.Glycerin

4.Magnesium chloride

5.Mannitol

6.Potassium chloride

7.Purified water

8.Stablized oxy cholro complex

9.Sodium tetra borate

10.Sodium hyaluronate

11.Sodium citrate

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

1.Excessive watering of the eye

2.Burning, stinging,foreign body sensation Continued redness (or) irritation of the eye, unusual eye secretions, change in vision

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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