REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [NAVARRO DISCOUNT PHARMACIES,LLC]

REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [NAVARRO DISCOUNT PHARMACIES,LLC]
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NDC 59970-050-05
Set ID 60cda9f7-60c0-4ca5-ac6e-2f35f7d6e6d5
Category HUMAN OTC DRUG LABEL
Packager Navarro Discount Pharmacies,LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • Active Ingredient

    Tetrahydrozoline HCl 0.5%
  • Purpose

    Redness reliever
  • Use

    • relieves 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.
    • do not use if this solution changes color or become cloudy
    • overuse may cause more eye redness
    • remove contact lens before using

    Stop use and ask a doctor if

    you experience:

    • eye pain
    • changes in vision
    • redness or irritation of the eye or if condition worsens or persists 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 right away.

  • Directions

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

  • Other information

    • store between 15° to 30°C (59°F to 86°F)

  • Inactive ingredients

    benzalkonium chloride, boric acid, dilite hydrochloric acid, edetate disodium, purified water, sodium borate, sodium chloride

  • package label

    Sterile Eye Drops Originalimage of carton label

  • INGREDIENTS AND APPEARANCE
    REDNESS RELIEVER  
    tetrahydrozoline hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-050
    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
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-050-051 in 1 BOX
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/02/2012
    Labeler - Navarro Discount Pharmacies,LLC (094930963)

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