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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51367-008
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE1 mg
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
SODIUM BORATE 
EDETATE DISODIUM 
THIMEROSAL 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51367-008-101 in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/01/1985
Labeler - International Nature Nutraceuticals (006106879)
Establishment
NameAddressID/FEIBusiness Operations
Hubei Kangzheng Pharmaceutical Co., Ltd530031426manufacture(51367-008)

Revised: 11/2013
Document Id: 8b3659b3-c0cb-4626-a8a4-90a4107b7ca3
Set id: e7aedab9-da4c-4494-a896-1e6ed2a956fe
Version: 2
Effective Time: 20131103
 
International Nature Nutraceuticals