drug facts - preservative free dry aid

drug facts - preservative free dry aid
SPL v4
SPL
SPL Set ID f4b1974c-2412-45f6-b79d-88b8a0bcb608
Route
ophthalmic
Published
Effective Date 2021-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
povidone, unspecified (6.8 mg) propylene glycol (3 mg)
Inactive Ingredients
boric acid calcium chloride edetate disodium magnesium sulfate anhydrous racementhol polyoxyl 35 castor oil peg/ppg-105/5 copolymer polyoxyl 40 stearate water sesame oil sodium borate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-06-03

Purpose

Povidone – Lubricant Propylene glycol - Lubricant

Description

Povidone 0.68% Propylene glycol 0.3%


Medication Information

Warnings

For external use only

Uses
  • temporarily relieves burning and irritation due to dryness of the eye
  • protects against further irritation or to relieve dryness of the eye
Purpose

Povidone – Lubricant

Propylene glycol - Lubricant

Directions
  • twist tab completely to remove; do not pull tab off
  • instill 1 or 2 drops in the affected eye(s) as needed
  • discard container

Other information

  • use only if single-use container is intact
  • do not freeze
Inactive Ingredients

boric acid, calcium chloride, edetate disodium, magnesium sulfate, menthol, PEG-10 castor oil, poloxamer, polyoxyl stearate, purified water, sesame oil, sodium borate

Description

Povidone 0.68% Propylene glycol 0.3%

Principal Display Panel
Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Active Ingredient

Povidone 0.68%

Propylene glycol 0.3%

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard
  • do not use if solution changes color or becomes cloudy
Stop Use and Ask A Doctor If
  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • 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

Warnings

For external use only

Uses
  • temporarily relieves burning and irritation due to dryness of the eye
  • protects against further irritation or to relieve dryness of the eye
Purpose

Povidone – Lubricant

Propylene glycol - Lubricant

Directions
  • twist tab completely to remove; do not pull tab off
  • instill 1 or 2 drops in the affected eye(s) as needed
  • discard container

Other information

  • use only if single-use container is intact
  • do not freeze
Inactive Ingredients (Inactive ingredients)

boric acid, calcium chloride, edetate disodium, magnesium sulfate, menthol, PEG-10 castor oil, poloxamer, polyoxyl stearate, purified water, sesame oil, sodium borate

Principal Display Panel
Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Active Ingredient (Active ingredient)

Povidone 0.68%

Propylene glycol 0.3%

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard
  • do not use 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 occur
  • redness or irritation of the eyes lasts
  • 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


Raw Label Data

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