Walgreens Sterile Original Eye: Package Insert and Label Information

WALGREENS STERILE ORIGINAL EYE- tetrahydrozoline hydrochloride solution/ drops
Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient Purpose

Tetrahydrozoline HCI 0.05……………………………………….. Redness reliever

Use

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

Warnings

For external use only.

Ask a doctor before use if you have narrow angle glaucoma

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

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

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 immediately.

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

Other information

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

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

Distributed by:

Walgreen Co.

200 Wilmot Rd.

Deerfield, IL 60015

Made in Korea

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WALGREENS STERILE ORIGINAL EYE
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7298
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
WATER
SODIUM BORATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-7298-15 2 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0363-7298-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 07/27/2015
Labeler — Walgreen Company (008965063)

Revised: 09/2015 Walgreen Company

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