Nazil Ofteno

naphazoline hydrochloride

Dosage Form: eye drops

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

NAZIL  OFTENO naphazoline hydrochloride  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 57619-300-01 1 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: 04/2010LABORATORIOS SOPHIA, S.A. DE C.V.

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