Rite Aid Original Sterile Eye
FDA Label NDC 11822-1536

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Original Sterile Eye (NDC 11822-1536). 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 ingredient                                        Purpose

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

Otc - Purpose

Use

  • for the relief of redness of the eye due to minor eye irritations

Warnings

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma.

Otc - When Using

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
  • do not touch tip of container to 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 alsts 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

  • to open bottle, push cap down and twist counterclockwise. 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

Storage And Handling

Other information

  • store at 15° to 25°C (59° to 77°F)

Inactive Ingredient

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Dosage & Administration

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN KOREA

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