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QUALITY CHOICE ORIGINAL EYE DROPS

Dosage form: solution
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-903

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 HCL 0.05%.........................................Redness reliever

Uses

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

Warnings

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
  • to avoid contamination, do not touch tip of container to any surface
  • 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 lasts
  • 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 right away.

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 at 15o to 25oC (59o to 77oF)

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

Distributed by

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

QUALITY CHOICE ORIGINAL EYE DROPS 
tetrahydrozoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-903
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
SODIUM CHLORIDE 
SODIUM BORATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63868-903-151 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/2012
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

 
CHAIN DRUG MARKETING ASSOCIATION INC

Medically reviewed on Mar 22, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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