Crocodile Tears Lubricant Eye Drops Solution/ Drops
FDA Label NDC 87522-115

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Crocodile Tears Llc for the product Crocodile Tears Lubricant Eye Drops (NDC 87522-115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

​Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

Otc - Purpose

​Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

Indications & Usage

​Uses

  • for protection against further irritation
  • for the temporary relief of burning and irritation due to dryness of the eye

Warnings

Warnings
For external use only
Do not use this product if solution changes color or becomes cloudy

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

    • remove contact lenses before using

      • 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

        • If pregnant or breast-feeding, ask a health professional before use.
        Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

Directions

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

Other Safety Information

Other information

Store at 15 o-30 oC (59 o-86 oF)

Inactive Ingredient

​Inactive ingredients

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

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