Naphcon A Solution/ Drops
FDA Label NDC 0065-0085

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Naphcon A (NDC 0065-0085). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredientsPurpose
Naphazoline hydrochloride 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Uses

for the temporary relief of redness and itching of the eye(s) due to:

  • ragweed
  • pollen
  • grass
  • animal dander and hair

Warnings

For external use only

Do Not Use

  • if you are sensitive to any ingredient in this product
  • if this solution changes color or becomes cloudy

Ask A Doctor Before Use If You Have

  • narrow angle glaucoma
  • heart disease
  • high blood pressure
  • trouble urinating

When Using This Product

  • pupils may become enlarged temporarily causing light sensitivity
  • overuse may cause more eye redness
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Stop Use And Ask A Doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep Out Of The Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

  • adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • protect from light

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

In the U.S. call 1-800-757-9195 or visit www.alcon.com

Principal Display Panel

100% MORE FREE
30 mL at 15 mL price!

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 30 mL (1 FL OZ)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines an antihistamine and a redness reliever for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2009, 2014, 2015 Novartis

9011948-0615

Alcon®
a Novartis company

LOT:
EXP.:

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 30 mL (1 FL OZ)

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Keep this and all drugs out of the reach of children.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).
Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13948-0615

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 15 mL (0.5 FL OZ)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Actual Size

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2008, 2014, 2015 Novartis

9011949-0615

Alcon®
a Novartis company

LOT:
EXP.:

15 mL Carton (15mlcarton)

15 mL Carton (15mlcarton)

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 15 mL (0.5 FL OZ)

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

Keep this and all drugs out of the reach of children.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).
Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13949-0615

POCKET SIZE

CONVENIENT
TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE Two 5 mL (0.16 FL OZ) Bottles

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

ACTUAL SIZE

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2004 - 2005, 2007, 2012, 2014, 2015 Novartis

9011956-0815

Alcon®
a Novartis company

LOT:
EXP.:

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

STERILE 5mL (0.16 FL OZ )

Alcon®

Active ingredients: Naphazoline hydrochloride 0.025%, Pheniramine maleate 0.3%.

Uses: For the temporary relief of redness and itching of the eye(s) due to ragweed, pollen, grass, animal dander and hair.

DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.

WARNINGS: See Drug Facts on outer carton for Warnings.

Keep this and all drugs out of the reach of children.

Remove contact lenses before using.

To avoid contamination, do not touch tip of container to any surface.

To open: push cap down while turning.
Replace cap after each use.

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.

Store at 20° - 25°C (68° - 77°F).

Protect from light.

ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
©2002, 2005, 2015 Novartis

LOT/EXP.:

H13950-0615

POCKET SIZE

CONVENIENT • TAKE ANYWHERE

NAPHCON A®
EYE DROPS

Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%

Redness Reliever and Antihistamine Eye Drops

Relieves Itching & Redness

EYE ALLERGY RELIEF

CLINICALLY PROVEN

STERILE 5 mL (0.16 FL OZ)

Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.

ACTUAL SIZE

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word "Alcon" around the neck. Do not use if seal is damaged or missing at time of purchase.

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134

©2002, 2004 - 2005, 2007, 2012 - 2015 Novartis

9011947-0615

Alcon®
a Novartis company

LOT:
EXP.:

* Please review the disclaimer below.