Family Wellness Artificial Tears 15ml (pld)

Family Wellness Artificial Tears 15ml (pld)
SPL v4
SPL
SPL Set ID facd329b-1923-61df-e053-6294a90ab738
Route
OPHTHALMIC
Published
Effective Date 2023-08-12
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
Sodium Chloride Sodium Phosphate, Dibasic Sodium Bicarbonate Sodium Phosphate, Monobasic Potassium Chloride Benzalkonium Chloride Dextrose Sodium Citrate Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-12

Description

Polyvinyl alcohol 0.5% Povidone 0.6%

Purpose

Lubricant Lubricant


Medication Information

Purpose

Lubricant Lubricant

Description

Polyvinyl alcohol 0.5% Povidone 0.6%

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
Purposes

Lubricant

Lubricant

Warnings

For external use only

Directions

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

Other Information
  • store at 15°-30°C (59°-86°F)
Active Ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-527-4276

When Using This Product
  • remove contact lens before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
Do Not Use This Product If
  • solution changes color or becomes cloudy
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 the Reach of Children.

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

Family Wellness Artificial Tears 15ml


Structured Label Content

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
Purposes

Lubricant

Lubricant

Warnings

For external use only

Directions

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

Other Information (Other information)
  • store at 15°-30°C (59°-86°F)
Active Ingredients (Active ingredients)

Polyvinyl alcohol 0.5%

Povidone 0.6%

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

Questions Or Comments? (Questions or comments?)

Call 1-888-527-4276

When Using This Product (When using this product)
  • remove contact lens before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
Do Not Use This Product If (Do not use this product if)
  • solution changes color or becomes cloudy
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 the Reach of Children. (Keep out of the reach of children.)

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

Family Wellness Artificial Tears 15ml (Family Wellness Artificial Tears 15mL)


Advanced Ingredient Data


Raw Label Data

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