CARE ONE EYE DROPS SEASONAL RELIEF

Dosage form: solution
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL, ZINC SULFATE 2.5mg in 1mL
Labeler: HANLIM PHARM. CO., LTD.
NDC Code: 11716-8653

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.

Drug Facts

Active Ingredients                                                               Purpose

Tetrahydrozoline HCL 0.05% ..............................................Redness Reliever

Zinc Sulfate 0.25% ............................................................Astringent

Uses

  • for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

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
  • 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 lasts
  • condition worsens or lasts more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
  • Store at 15o to 25oC (59o to 77Fo)
  • Children under  6 years of age: Ask a doctor

Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

Distributed By:

American Sales Co.

4201 Walden Ave.

Lancaster, NY 14086

Enter section text here

CARE ONE EYE DROPS SEASONAL RELIEF 
tetrahydrozoline hydrochloride and zinc sulfate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-8653
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
ZINC SULFATE (ZINC) ZINC SULFATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
WATER 
SODIUM CHLORIDE 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:11716-8653-31 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/02/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIOperations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 11/2010
 
HANLIM PHARM. CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)