SPL v3
SPL
SPL Set ID 29d7614b-f4b7-48e2-97c5-d1bff27731d2
Route
OPHTHALMIC
Published
Effective Date 2026-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (0.5 g) Glycerin (1 g) Peg-20 Sorbitan Oleate
Inactive Ingredients
Arginine Edetate Disodium Boric Acid Cyanocobalamin Potassium Chloride Water Pyridoxine Hydrochloride Sodium Chloride Sodium Citrate Sodium Chlorite Taurine .alpha.-tocopherol Acetate Trehalose Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Purpose

Lubricant


Medication Information

Purpose

Lubricant

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Uses

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

For use as a protectant against further irritation

Section 50565-1

Warnings

For external use only

Do not use if solution changes color

When using this product

• Do not touch tip of the container to any surface to avoid contamination

• Replace cap after each use

Stop use and ask a doctor if

• If you feel eye pain

• Changes in vision occur

• Redness or irritation of the eye lasts

• Condition worsens 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

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

  • Tightly screw on cap to seal after use.
Product Label

Other Information

Store at 20 - 25°C (68 -77°F)

Active Ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients

L-arginine (amino acid), boric acid, cyanocobalamin (Vitamin B12), edetate disodium, potassium chloride, purified water, pyridoxine hydrochloride (Vitamin B6), sodium chloride, sodium citrate, stabilized oxychloro complex, taurine (amino acid), tocopherol acetate (Vitamin E), trehalose, sodium hydroxide and/or hydrochloric acid (to adjust pH)


Structured Label Content

Uses

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

For use as a protectant against further irritation

Section 50565-1 (50565-1)

Purpose

Lubricant

Warnings

For external use only

Do not use if solution changes color

When using this product

• Do not touch tip of the container to any surface to avoid contamination

• Replace cap after each use

Stop use and ask a doctor if

• If you feel eye pain

• Changes in vision occur

• Redness or irritation of the eye lasts

• Condition worsens 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

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

  • Tightly screw on cap to seal after use.
Product Label (Product label)

Other Information (Other information)

Store at 20 - 25°C (68 -77°F)

Active Ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients (Inactive ingredients)

L-arginine (amino acid), boric acid, cyanocobalamin (Vitamin B12), edetate disodium, potassium chloride, purified water, pyridoxine hydrochloride (Vitamin B6), sodium chloride, sodium citrate, stabilized oxychloro complex, taurine (amino acid), tocopherol acetate (Vitamin E), trehalose, sodium hydroxide and/or hydrochloric acid (to adjust pH)


Advanced Ingredient Data


Raw Label Data

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