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Dosage form: solution/ drops
Ingredients: Polysorbate 80 100mg in 10mL
Labeler: Dakota Laboratories, LLC
NDC Code: 54891-001

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.

Drug Facts

Active ingredients

Polysorbate 80 (1.0%)


Eye Lubricant

Keep out of reach of children• Keep this and all drugs out of the reach of children.

• Temporarily relieves burning and irritation due to dryness of the eye.
• Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.
• Protects against further irritation or relieves dryness of the eye.
• Lubricates to prevent further irritation or to relieve dryness of the eye.

• To avoid contamination, do not touch tip of container to any surface.

• Replace cap after using

• If you experience pain, changes in vision, continued redness or irritation of the eye, or if the condition persists for more than 72 hours, discontinue use and consult a doctor.

• If solution changes color or becomes cloudy, do not use.

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

purified water, sodium chloride, citric acid, edetate disodium with retinyl palmitate, mannitol, sodium citrate, and pyruvate as antioxidants.

polysorbate 80 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54891-001
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polysorbate 80 (Sorbitan ) Polysorbate 80100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE60.5 mg  in 10 mL
Citric Acid.34 mg  in 10 mL
Edetate Disodium5 mg  in 10 mL
Mannitol18 mg  in 10 mL
Sodium Citrate73.6 mg  in 10 mL
Sodium Pyruvate5 mg  in 10 mL
#Item CodePackage Description
1NDC:54891-001-0210 mL in 1 BOTTLE
2NDC:54891-001-04.5 mL in 1 VIAL, SINGLE-USE
3NDC:54891-001-03.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/19/1987
Labeler - Dakota Laboratories, LLC (002303871)
Dakota Laboratories, LLC002303871manufacture

Revised: 01/2012
Dakota Laboratories, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.