Label: EYE DROPS ADVANCED RELIEF- tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops

  • NDC Code(s): 55651-025-01
  • Packager: KC Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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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Updated October 8, 2019

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  • ACTIVE INGREDIENT

    Active ingredients

    Dextran 70 0.1%

    Polyethylene glycol 400 1%

    Povidone 1%

    Tetrahydrozoline HCl 0.05%

  • PURPOSE

    Purposes

    Dextran 70..................Lubricant

    Polyethylene glycol 400....Lubricant

    Povidone...........................Lubricant

    Tetrahydrozoline HCl........Redness reliever

  • INDICATIONS & USAGE

    Uses

    • relieves redness of the eye due to minor eye irritations
    • as a lubricant to prevent further irritation or to relieve dryness of the eye
  • WARNINGS

    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 lens 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.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • OTHER SAFETY INFORMATION

    Other information

    store at 15°-30°C (59°-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

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

    sodium chloride

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    EYE DROPS ADVANCED RELIEF 
    tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-025
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55651-025-011 in 1 CARTON12/09/2003
    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 finalpart34912/09/2003
    Labeler - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(55651-025) , pack(55651-025) , label(55651-025)
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