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Nazil Ofteno

Dosage form: solution/ drops
Ingredients: Naphazoline Hydrochloride 0.20mg in 1mL
Labeler: LABORATORIOS SOPHIA, S.A. DE C.V.
NDC Code: 57619-300

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.

DRUG FACTS


Active Ingredient

Naphazoline Hydrochloride 0.02%

Purpose

Redness reliever

Uses
  • 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 have narrow 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
  • Changes in vision
  • Continued redness or irritation of the eye
  • 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 Eye Drops

0.5 FL OZ (15mL)

Sterile

NAZIL  OFTENO
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-300
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride0.20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
boric acid 
water 
sodium borate 
sodium chloride 
Packaging
#Item CodePackage Description
1NDC:57619-300-011 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/12/2010
Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
Establishment
NameAddressID/FEIOperations
LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-300)

Revised: 12/2012
Document Id: b0ecc05d-727a-466b-8d09-20cce7d149e8
Set id: fec3c242-eac5-4249-942b-0b772aa9e7d9
Version: 3
Effective Time: 20121210
 
LABORATORIOS SOPHIA, S.A. DE C.V.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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