Rexall Sterile Artificial Tears Eye Drops
FDA Label NDC 55910-522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp Inc for the product Rexall Sterile Artificial Tears Eye Drops (NDC 55910-522). 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, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, 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                                                                              Purpose

Glycerin 0.2%..................................................................................Lubricant

Hypromellose 0.2%..........................................................................Lubricant

Polyethylene glycol 400 1%..............................................................Lubricant

Otc - Purpose

Uses

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

Warnings

Warnings for external use only

Otc - When Using

When using this product

  • remove contact lenses before use
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container or any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or last more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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

Indications & Usage

Directions

  • put 1 to 2 drops in the affected eye(s) as needed.
  • children under 6 years of age: ask a doctor.

Storage And Handling

Other information

  • some users may experience a brief tingling sensation
  • store at 15° to 25°C (59°-77°F)

Inactive Ingredient

Inactive ingredients benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate.

Dosage & Administration

Packaged For:

Dolgencorp, LLC

100 Mission Ridge

Goodlettsville, TN 37072 USA

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Rexallartificialtears)

Image Of Carton Label (Rexallartificialtears)

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