Label: CAREONE ITCHY RELIEF EYE DROPS 15ML- tetrahydrozoline hci, zinc sulfate liquid

  • NDC Code(s): 72476-011-01
  • Packager: Retail Business Services, LLC.
  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated December 12, 2019

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  • Active ingredients

    Tetrahydrozoline HCI 0.05%

    Zinc sulfate 0.25%

  • Purposes

    Redness reliever

    Astringent

  • Uses

    • for temporary relief of discomfort and redness of the eye 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
    • 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

  • INGREDIENTS AND APPEARANCE
    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)
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