Active Ingredients
Naphazoline Hydrochloride: 0.01%
Purpose: Eye redness reliever
Pi Yuan Chin Solution/ Drops
FDA Label NDC 51367-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Nature Nutraceuticals for the product Pi Yuan Chin (NDC 51367-035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings: for external use only, directions:, other information, inactive ingredients, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves redness due to minor irritation of eye
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
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.
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.
Inactive Ingredients
Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Distilled Water
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