Label: 7 SELECT REDNESS RELIEF- glycerin and naphazoline hci 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 November 27, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                  Purpose

    Glycerin 0.25%......................................Lubricant

    Naphazoline HCI 0.012%.........................Redness reliever

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  • PURPOSE

    Uses

    • relieves redness of the eye due to minior eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
    • for the temporary relief of burning and irritation due to dryness of the eye
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  • WARNINGS

    Warings

    For external use only

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  • DO NOT USE

    Do not use if solution changes color or becomes cloudy

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  • ASK DOCTOR

    Ask a doctor before use if you have narrow angle glaucoma

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  • WHEN USING

    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

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  • STOP USE

    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
    • symptoms last for more than 72 hours
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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  • INDICATIONS & USAGE

    Directions

    • to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
    • instil 1 to 2 drops in the affected eye(s) up to four time daily
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • remove contact lenses before using
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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    7-Elevin, Inc.

    Irving TX 75063

    www.7-eleven.com

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  • INGREDIENTS AND APPEARANCE
    7 SELECT REDNESS RELIEF 
    glycerin and naphazoline hci solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-850
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.00012 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.0025 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10202-850-15 1 in 1 BOX 03/28/2017
    1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 03/28/2017
    Labeler - 7-Select, Inc (007347602)
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