CAREONE ITCHY RELIEF EYE DROPS 15ML- tetrahydrozoline hci, zinc sulfate liquid 
Retail Business Services, LLC.

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.

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Active ingredients

Tetrahydrozoline HCI 0.05%

Zinc sulfate 0.25%

Purposes

Redness reliever

Astringent

Uses

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
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lenses before using

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for 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 (1-800-222-1222) right away.

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Careone Itchy Relief Eye Drops 15mL

Careone Itchy Relief Eye Drops 15mL

CAREONE ITCHY RELIEF EYE DROPS 15ML 
tetrahydrozoline hci, zinc sulfate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-011
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.25 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-011-011 in 1 BOX10/29/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/29/2019
Labeler - Retail Business Services, LLC. (967989935)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(72476-011) , pack(72476-011) , label(72476-011)

Revised: 12/2019
Document Id: 997f1656-4636-91d1-e053-2a95a90adbdf
Set id: 997f16ff-2632-2e9d-e053-2995a90a6f51
Version: 1
Effective Time: 20191212
 
Retail Business Services, LLC.