Label: REDNESS RELIEVER- tetrahydrozoline hcl liquid

  • 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.

Drug Label Information

Updated August 11, 2011

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  • 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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