Family Care Advanced Formula Eye
FDA Label NDC 65923-511

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Family Care Advanced Formula Eye (NDC 65923-511). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, other safety information, 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

Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

Dextran 70 0.1%............................................................................Lubricant

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

Povidone 1%.................................................................................Lubricant

Otc - Purpose

Uses

  • for the relief of redness of the eyes due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye

    • When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use

Warnings

Warnings

For external use only

Otc - Stop Use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye persists
  • condition worsens or lasts 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Other Safety Information

Other information

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

Inactive Ingredient

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave,

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (511.1)

Image Description (511.1)

* Please review the disclaimer below.