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Name:Nazilofteno
Manufacturer:Laboratorios Sophia, S.a. De C.v.
Category:Over-the-counter (OTC) Marketed Drugs


NAZIL OFTENO - naphazoline hydrochloride solution/ drops 
LABORATORIOS SOPHIA, S.A. DE C.V.

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

DRUG FACTS

Active Ingredient

Naphazoline Hydrochloride 0.02%

Purpose

Redness reliever

Use

  • Relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use

if you havenarrow angle glaucoma

When using this product

  • Do not touch tip of container to any surface to avoid contamination
  • Replace cap after using
  • Overuse may cause more redness of the eye
  • Puplis may become enlarged temporarily

Stop use and ask a doctor if

  • You feel eye pain
  • Change in vision occur
  • Redness or irritation of the eye lasts
  • Condition worsens
  • Symptoms last for more than 72 hours

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

  • Store at room temperature
  • Remove contact lenses before using

Inactive ingredients

benzalkonium chloride (as preservative), boric acid, purified water, sodium borate, sodium chloride

Questions?

Call 1-866-282-8871

www.sophia.com.mx

Principal Display Panel

NDC 57619-300-01

Nazil Ofteno

Redness Reliever Eyedrops

0.5 FL OZ (15mL)

Sterile

Principal Display Panel


NAZIL  OFTENO
naphazoline hydrochloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57619-300
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride 0.20 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57619-300-01 1 BOTTLE, PLASTIC ( BOTTLE) in 1 PACKAGE contains a BOTTLE, PLASTIC
1 15 mL in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (57619-300-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 04/12/2010

Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
Establishment
Name Address ID/FEI Operations
LABORATORIOS SOPHIA, S.A. DE C.V. 810143636 manufacture

Revised: 04/2010 LABORATORIOS SOPHIA, S.A. DE C.V.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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