Kroger Artificial Tears 15ml (pld)

Kroger Artificial Tears 15ml (pld)
SPL v3
SPL
SPL Set ID f76f08c5-0111-8bc5-e053-6294a90a16ee
Route
OPHTHALMIC
Published
Effective Date 2023-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Povidone (0.6 g) Polyvinyl Alcohol, Unspecified (0.5 g)
Inactive Ingredients
Potassium Chloride Benzalkonium Chloride Edetate Disodium Water Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Dextrose Sodium Bicarbonate Sodium Chloride Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-20

Description

Active ingredients Polyvinyl alcohol........0.5% Povidone....................0.6%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Dosage and Administration

Directions

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

Description

Active ingredients Polyvinyl alcohol........0.5% Povidone....................0.6%

Section 50565-1

Keep out of the reach of children. If accidentally 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
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
Section 50567-7

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
  • remove contact lens before using
Section 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 55105-1

Purpose

Polyvinyl alcohol............Eye lubricant

Povidone........................Eye lubricant

Section 55106-9

Active ingredients

Polyvinyl alcohol........0.5%

Povidone....................0.6%

Section 60561-8

Other information

  • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15º-30ºC (59º-86ºF)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of the reach of children. If accidentally 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
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
  • remove contact lens before using
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Polyvinyl alcohol............Eye lubricant

Povidone........................Eye lubricant

Section 55106-9 (55106-9)

Active ingredients

Polyvinyl alcohol........0.5%

Povidone....................0.6%

Section 60561-8 (60561-8)

Other information

  • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15º-30ºC (59º-86ºF)

Advanced Ingredient Data


Raw Label Data

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