T-RAOJO (TETRAHYDROZOLINE HYDROCHLORIDE) LIQUID [PROMEX, LLC]

T-RAOJO (TETRAHYDROZOLINE HYDROCHLORIDE) LIQUID [PROMEX, LLC]
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NDC 58988-0148-5
Set ID 779d736d-0d1a-47a1-b5b0-f7fc7d44d383
Category HUMAN OTC DRUG LABEL
Packager Promex, LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • Active Ingredient

    • Tetrahydrozoline HCl 0.5%
  • Purpose

    • Redness reliever
  • Use

    • for the relief of 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
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or become cloudy
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts 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

    • Put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age:  ask a doctor
  • Other information

    • store between 15° to 25°C (59°F to 77°F)


  • Inactive ingredients

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

  • package label

    Redness relief

    image of carton label

  • INGREDIENTS AND APPEARANCE
    T-RAOJO 
    tetrahydrozoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0148
    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:58988-0148-51 in 1 BOX
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/17/2014
    Labeler - Promex, LLC (789974388)

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