7 SELECT REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HCI) SOLUTION/ DROPS [7-SELECT, INC]

7 SELECT REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HCI) SOLUTION/ DROPS [7-SELECT, INC]
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NDC 10202-850-15
Set ID b850bed8-8d6d-44ed-976e-3a7b6b696371
Category HUMAN OTC DRUG LABEL
Packager 7-Select, Inc
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                  Purpose

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

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

  • PURPOSE

    Uses

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

    Warings

    For external use only

  • DO NOT USE

    Do not use if solution changes color or becomes cloudy

  • ASK DOCTOR

    Ask a doctor before use if you have narrow angle glaucoma

  • WHEN USING

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using
    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using

  • STOP 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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).

  • INDICATIONS & USAGE

    Directions

    • to open bottle, push cap down and twist counter-clockwise
    • instill 1 to 2 drops in the affected eye(s) up to four time daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 15-25 C (59-77F)
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    7-Elevin, Inc.

    Irving TX 75063

    www.7-eleven.com

  • PRINCIPAL DISPLAY PANEL

    Redness Relief Eye Drops

  • INGREDIENTS AND APPEARANCE
    7 SELECT REDNESS RELIEF 
    glycerin and naphazoline hci solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-850
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.00012 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0025 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10202-850-151 in 1 BOX03/28/2017
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/28/2017
    Labeler - 7-Select, Inc (007347602)

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