CARE ONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hydrochloride and zinc sulfate solution 
HANLIM PHARM. CO., LTD.

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.

----------

Careone Eye Drops Seasonal Relief 0.5 oz (NBE Visine AC)

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 15 o to 25 oC (59 o to 77F o)
  • 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

image of carton labelEnter 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 AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-8653-31 in 1 CARTON11/02/201009/26/2018
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/02/201009/26/2018
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)

Revised: 9/2018
 
HANLIM PHARM. CO., LTD.