Label: REDNESS RELIEVER- tetrahydrozoline hcl liquid

  • NDC Code(s): 41520-531-05
  • Packager: American Sales Company
  • 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 February 17, 2023

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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


    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 right away.

  • Directions

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

    • Store at 15° to 30°C (59°F to 86°F)


  • Inactive ingredients

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

  • package label

    Care One Redness Reliever

    carton

  • INGREDIENTS AND APPEARANCE
    REDNESS RELIEVER 
    tetrahydrozoline hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-531
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-531-051 in 1 BOX09/06/2011
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/06/2011
    Labeler - American Sales Company (809183973)
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