Perfectears
FDA Label NDC 84535-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cetel Scientific Llc for the product Perfectears (NDC 84535-001). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye Lubricant

Uses

  • For temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun
  • protectant against further irritation

Warnings

For external use only.

Do not useif solution changes color or becomes cloudy

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse. Once opened, discard.

    • Stop use and ask a doctor if

    • you experience 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

  • To open, TWIST AND PULL TAB TO REMOVE.
  • Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other Information

  • use before expiration date marked on container.
  • store at 59°-86°F (15°-30°C).

Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, gelatin, sodium chloride; and sodium lactate.May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Product Label

Image Description (Image 1)

Image Description (Image 1)

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