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SPL v16

SPL

SPL Set ID aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0

Route

OPHTHALMIC

Published

Effective Date 2022-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Carboxymethylcellulose (5 mg) Glycerin (10 mg) Polysorbate 80

Inactive Ingredients

Boric Acid Carbomer Copolymer Type A Castor Oil Erythritol Levocarnitine Water Sodium Chlorite Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2011-11-30 Until 2016-12-10

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Purpose

Eye lubricant Eye lubricant Eye lubricant

Medication Information

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%

Uses

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
May be used as a protectant against further irritation.

Warnings

For external use only.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
If solution changes color, do not use.

Directions

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

Other Information

Use only if tape seals on top and bottom flaps are intact.
Use before expiration date marked on container.
Discard 90 days after opening.
Store at 59°-77°F (15°-25°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Active Ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; puriﬁed water; PURITE® (stabilized oxychloro complex); and sodium hydroxide (to adjust pH).

Questions Or Comments?

1.800.678.1605

refresh eyedrops .com

v1.0DFL4307

Principal Display Panel

NDC 0023-4307-10

Refresh

OPTIVE®

ADVANCED

Lubricant Eye Drops

with Hydrocell^®

Triple-Action Relief

For Dry Eyes

0.33 fl oz (10 mL) Sterile

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 persists for more than 72 hours.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
May be used as a protectant against further irritation.

Purpose

Eye lubricant

Warnings

For external use only.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
If solution changes color, do not use.

Directions

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

Other Information (Other information)

Use only if tape seals on top and bottom flaps are intact.
Use before expiration date marked on container.
Discard 90 days after opening.
Store at 59°-77°F (15°-25°C).
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Active Ingredients (Active ingredients)

Carboxymethylcellulose sodium 0.5%

Glycerin 1%

Polysorbate 80 0.5%

Inactive Ingredients (Inactive ingredients)

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; puriﬁed water; PURITE® (stabilized oxychloro complex); and sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

1.800.678.1605

refresh eyedrops .com

v1.0DFL4307

Principal Display Panel

NDC 0023-4307-10

Refresh

OPTIVE®

ADVANCED

Lubricant Eye Drops

with Hydrocell^®

Triple-Action Relief

For Dry Eyes

0.33 fl oz (10 mL) Sterile

Stop Use and Ask A Doctor If (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 persists for more than 72 hours.

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

[{"name": "CARBOXYMETHYLCELLULOSE", "unii": "05JZI7B19X", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER COPOLYMER TYPE A", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ERYTHRITOL", "unii": "RA96B954X6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOCARNITINE", "unii": "0G389FZZ9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORITE", "unii": "G538EBV4VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.", "Purpose": "Eye lubricant Eye lubricant Eye lubricant", "Warnings": "For external use only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If solution changes color, do not use.", "Directions": "Instill 1 or 2 drops in the affected eye(s) as needed.", "Other information": "Use only if tape seals on top and bottom flaps are intact. Use before expiration date marked on container. Discard 90 days after opening. Store at 59°-77°F (15°-25°C). RETAIN THIS CARTON FOR FUTURE REFERENCE.", "Active ingredients": "Carboxymethylcellulose sodium 0.5% Glycerin 1% Polysorbate 80 0.5%", "Inactive ingredients": "Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; puriﬁed water; PURITE® (stabilized oxychloro complex); and sodium hydroxide (to adjust pH).", "Questions or comments?": "1.800.678.1605 refresh eyedrops .com v1.0DFL4307", "Principal Display Panel": "NDC 0023-4307-10 Refresh OPTIVE® ADVANCED Lubricant Eye Drops with Hydrocell ® Triple-Action Relief For Dry Eyes 0.33 fl oz (10 mL) Sterile", "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 persists for more than 72 hours.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.792742 · Updated: 2026-03-14T23:13:02.501548