PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]

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PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]
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NDC 20146-7000-1
Set ID c0234e82-211f-4731-ac48-12db13b16e8a
Category HUMAN OTC DRUG LABEL
Packager SAMSON PHARMACEUTICAL
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    DRUG FACT

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    Naphazoline HCL 0.01%Redness reliever
    Glycerin 0.25%Lubricant
  • Uses

    ♦
    Relieve redness of the eye due to minor irritation
    ♦
    Temporary relief of burning and irritation due to dryness of the eye
    ♦
    Protects against further irritation
  • 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

    ♦
    Do not touch tip of container to any surface to avoid contamination
    ♦
    Do not overuse as it may products increased redness of the eye
    ♦
    Pupils may be come enlarged temporarily
    ♦
    Remove contact lenses before using
    ♦
    Replace cap after use

    Stop use and ask a doctor if

    ♦
    You experience eye pain, changes in vision, continued redness or irritation of the eyes
    ♦
    Conditions worsens or persists for more than 72 hours

    Keep put of reach of children. Id swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    ♦
    Store at 15- 30 C (59-86 F)
    ♦
    Keep tightly closed
    ♦
    Use before expiration date marked on the carton and bottle
    ♦
    Serious side effect associated with use of the product may be reported to the phone number provided below
  • Inactive ingredients

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

  • Question?

    1-888-995-9935

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Samson Pharmaceutical
    Commerce, CA 90040
    Made in USA

  • PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

    POCKET SIZE

    MAXIMUM
    REDNESS RELIEF

    Pure
    Eyes®

    STERILE
    EYE DROPS

    ✓
    Relieves
    ✓
    Protects
    ✓
    Soothes
    ✓
    Moisturizes

    Made in the U.S.A.

    0.24 FL OZ (7ML)

    Principal Display Panel - 7 mL Bottle Blister Pack
  • INGREDIENTS AND APPEARANCE
    PURE EYES STERILE EYES 
    naphazoline hydrochloride and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20146-7000
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.1 mg  in 1 mL
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2.5 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:20146-7000-11 in 1 BLISTER PACK01/01/2015
    17 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34901/01/2015
    Labeler - SAMSON PHARMACEUTICAL (088169581)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMSON PHARMACEUTICAL088169581MANUFACTURE(20146-7000)
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