Topcare Health Dry Eye (pld)

SPL v3

SPL

SPL Set ID 9c617e34-fc66-1a5b-e053-2995a90ace2c

Route

OPHTHALMIC

Published

Effective Date 2020-02-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polyethylene Glycol 400 (1 g) Hypromellose, Unspecified (0.2 g) Glycerin

Inactive Ingredients

Benzalkonium Chloride Dextrose Potassium Chloride Water Sodium Bicarbonate Sodium Chloride Sodium Phosphate, Monobasic Edetic Acid Sodium Citrate Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-06

Description

Glycerin ................... 0.2% Hypromellose ........... 0.2% Polyethylene glycol 400 ......1%

Purpose

Glycerin.......................Lubricant Hypromellose..............Lubricant Polyethylene glycol 400.........Lubricant

Medication Information

Purpose

Glycerin.......................Lubricant Hypromellose..............Lubricant Polyethylene glycol 400.........Lubricant

Description

Glycerin ................... 0.2% Hypromellose ........... 0.2% Polyethylene glycol 400 ......1%

Uses

for protection against further irritation
for temporary relief of burning and irritation due to dryness of the eye

Section 50570-1

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

Section 51945-4

Purposes

Glycerin.......................Lubricant

Hypromellose..............Lubricant

Polyethylene glycol 400.........Lubricant

Warnings

For external use only

Directions

instill 1 to 2 drops in the affected eye(s) as needed
children under 6 years of age: ask a doctor

Other Information

store at 15º-30ºC (59º-86ºF)

Active Ingredients

Glycerin ................... 0.2%

Hypromellose ........... 0.2%

Polyethylene glycol 400 ......1%

Inactive Ingredients

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

When Using This Product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

Stop Use and Ask A Doctor

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

for protection against further irritation
for temporary relief of burning and irritation due to dryness of the eye

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Purposes

Glycerin.......................Lubricant

Hypromellose..............Lubricant

Polyethylene glycol 400.........Lubricant

Warnings

For external use only

Directions

instill 1 to 2 drops in the affected eye(s) as needed
children under 6 years of age: ask a doctor

Other Information (Other information)

store at 15º-30ºC (59º-86ºF)

Active Ingredients (Active ingredients)

Glycerin ................... 0.2%

Hypromellose ........... 0.2%

Polyethylene glycol 400 ......1%

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

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

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CHLORIDE", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye", "50570-1": "Do not use this product if solution changes color or becomes cloudy", "Purposes": "Glycerin.......................Lubricant Hypromellose..............Lubricant Polyethylene glycol 400.........Lubricant", "Warnings": "For external use onl y", "Directions": "instill 1 to 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor", "Other information": "store at 15º-30ºC (59º-86ºF)", "Active ingredients": "Glycerin ................... 0.2% Hypromellose ........... 0.2% Polyethylene glycol 400 ......1%", "Inactive ingredients": "benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic", "When using this product": "to avoid contamination, do not touch tip of container to any surface. Replace cap after using.", "Stop use and ask a doctor": "eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed , get medical help or contact a Poison Control Center (1-800-222-1222), right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:33.509009 · Updated: 2026-03-14T23:02:10.811423