Label: EQUATE REDNESS RELIEVER- tetrahydrozoline hydrochloride solution/ drops

  • 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 January 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tetrahydrozoline Hydrochloride 0.05%

  • Purpose

    Redness reliever

  • Uses

    • relieves redness of the eye due to minor eye irritations
  • Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    • narrow angle glaucoma

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using
    • overuse may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens or persists for more than 72 hours

    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 four times daily
  • Other information

    • store at room temperature
    • remove contact lenses before using
  • Inactive ingredients

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

  • Questions?

    1-888-287-1915

  • Principal Display Panel

    Equate®
    Original Redness Reliever
    Tetrahydrozoline HCI
    Sterile Eye Drops
    1 FL OZ (30 mL)

    Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 1 FL OZ (30 mL)

  • Principal Display Panel

    Equate®
    Original Redness
    Reliever
    Tetrahydrozoline HCI
    Sterile Eye Drops
    0.5 FL OZ (15 mL)

    Equate® Original Redness Reliever Tetrahydrozoline HCI Sterile Eye Drops 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    EQUATE REDNESS RELIEVER 
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-010
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-010-151 in 1 CARTON04/26/2013
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:79903-010-301 in 1 CARTON04/26/2013
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/26/2013
    Labeler - WALMART INC. (051957769)
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