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
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.
Updated July 27, 2017
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- Active Ingredients
Naphazoline Hydrochloride: 0.01%
Purpose: Eye redness relieverClose
Temporarily relieves redness due to minor irritation of eyeClose
- 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 temporarilyClose
- Keep out of reach of Children
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.Close
- 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.Close
- Inactive Ingredients
Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Distilled WaterClose
- INGREDIENTS AND APPEARANCE
PI YEN CHIN
naphazoline hydrochloride solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51367-008 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 1 mg Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) EDETATE DISODIUM (UNII: 7FLD91C86K) THIMEROSAL (UNII: 2225PI3MOV) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51367-008-10 1 in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 07/01/1985 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)