Label: PURE EYES STERILE EYES- naphazoline hydrochloride and glycerin 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 February 10, 2020

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

  • 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)