REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]

REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]
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NDC 41520-531-05
Set ID 3222b6d6-adb6-4747-b764-84a19bd5cc34
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
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


    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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