Dry Eye Relief: Package Insert and Label Information

DRY EYE RELIEF- polyethylene glycol 400 and propylene glycol gel
Cardinal Health, 110 dba LEADER

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients Purpose
Polyethylene Glycol 400 0.4% Lubricant
Propylene Glycol 0.3% Lubricant

Uses

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

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

Stop use and ask a doctor if you experience any of the following:

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • 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.

Directions

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed

Other information

  • store at room temperature

Inactive ingredients

boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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DRY EYE RELIEF
polyethylene glycol and propylene glycol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0088
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 400 4 mg in 1 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORITE
BORIC ACID
EDETATE DISODIUM
MAGNESIUM CHLORATE
POTASSIUM CHLORATE
HYPROMELLOSE, UNSPECIFIED
SODIUM CHLORIDE
SODIUM BORATE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0088-1 10 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 03/09/2021
Labeler — Cardinal Health, 110 dba LEADER (063997360)

Revised: 06/2021 Cardinal Health, 110 dba LEADER

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