SPL v2
SPL
SPL Set ID d1b30723-e2b1-4772-a11e-57ba9acc9343
Route
OPHTHALMIC
Published
Effective Date 2014-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Chlorhexidine Gluconate Hydrochloric Acid Hypromellose 2910 (5 Mpa.s) Magnesium Chloride Potassium Chloride Water Sodium Chloride Sodium Hydroxide Zinc Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-04-01

Description

Active ingredients                                                             Purpose Polyethylene Glycol 400 0.4%--------------------------------- Lubricant Propylene Glycol 0.3%----------------------------------------- Lubricant


Medication Information

Warnings and Precautions

Warnings

For external use only.

retain carton for full product drug facts

Indications and Usage

Directions

  • Put 1 or 2 drops in the affected eye/s as needed
Dosage and Administration

DISTRIBUTED BY:

WAL-MART STORES, INC.

BENTONVILLE, AR 72716

MADE IN KOREA

Description

Active ingredients                                                             Purpose Polyethylene Glycol 400 0.4%--------------------------------- Lubricant Propylene Glycol 0.3%----------------------------------------- Lubricant

Section 44425-7

Other information

  • store at room temperature 15o-30oC (59o-86oF)
Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
Section 50567-7

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Section 50570-1

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive or allergic to any ingredient in this product
Section 51727-6

Inactive ingredients

boric acid, calcium chloride, 20% chlorhexidine gluconate, hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

Section 51945-4

Section 55105-1

Uses

For the temporary relief of burning and irritation due to eye dryness.

Section 55106-9

Active ingredients                                                             Purpose

Polyethylene Glycol 400 0.4%--------------------------------- Lubricant

Propylene Glycol 0.3%----------------------------------------- Lubricant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • Put 1 or 2 drops in the affected eye/s as needed
Dosage and Administration (34068-7)

DISTRIBUTED BY:

WAL-MART STORES, INC.

BENTONVILLE, AR 72716

MADE IN KOREA

Warnings and Precautions (34071-1)

Warnings

For external use only.

retain carton for full product drug facts

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15o-30oC (59o-86oF)
Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Section 50570-1 (50570-1)

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive or allergic to any ingredient in this product
Section 51727-6 (51727-6)

Inactive ingredients

boric acid, calcium chloride, 20% chlorhexidine gluconate, hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

For the temporary relief of burning and irritation due to eye dryness.

Section 55106-9 (55106-9)

Active ingredients                                                             Purpose

Polyethylene Glycol 400 0.4%--------------------------------- Lubricant

Propylene Glycol 0.3%----------------------------------------- Lubricant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)