PI YEN CHIN- naphazoline hydrochloride solution/ drops 
International Nature Nutraceuticals

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.

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Drug Facts

Active Ingredients

Naphazoline Hydrochloride: 0.01%

Purpose: Eye redness reliever

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

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.

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

Packaging

package

PI YEN CHIN 
naphazoline hydrochloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51367-008
Route of Administration OPHTHALMIC DEA Schedule     
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
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 544321544 manufacture(51367-008)

Revised: 3/2015
Document Id: 4c5b96b4-d198-433e-b502-9d7d0a2006a6
Set id: e7aedab9-da4c-4494-a896-1e6ed2a956fe
Version: 3
Effective Time: 20150330
 
International Nature Nutraceuticals