Label: PI YEN CHIN- naphazoline hydrochloride solution/ drops 

  • NDC Code(s): 51367-008-10
  • Packager: International Nature Nutraceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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  • Active Ingredients

    Naphazoline Hydrochloride: 0.01%

    Purpose: Eye redness reliever

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  • Uses

    Temporarily relieves redness due to minor irritation of eye

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  • Warnings: For external use only

    Do not use if allergic to any of the ingredients.

    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, discontinue use and consult a doctor.

    Ask a doctor before use if you have narrow angle glaucoma.

    Overuse of this product may produce increased redness of the eye.

    If solution changes color or becomes cloudy, do not use.

    When using this product pupils may become enlarged temporarily

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  • Keep out of reach of Children
  • Directions:

    1 to 2 drops instilled into the affected eye(s) 1 to 4 times a day. Do not use for children under the age of 6.

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  • Other Information

    To prevent contaminating the dropper tip and solution, care should be taken not to touch any surface, the eyelids, or surronding area with the dropper tip of the bottle. Replace cap after using. Keep bottle tightly closed when not in use and store in a cool dry place. Do not use if seal is broken.

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  • Inactive Ingredients

    Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Distilled Water

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    PI YEN CHIN 
    naphazoline hydrochloride solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51367-008
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    SODIUM BORATE  
    EDETATE DISODIUM  
    THIMEROSAL  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51367-008-10 1 in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 07/01/1985
    Labeler - International Nature Nutraceuticals (006106879)
    Establishment
    Name Address ID/FEI Business Operations
    Hubei Kangzheng Pharmaceutical Co., Ltd 530031426 manufacture(51367-008)
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