NDC 0065-0085 Naphcon A

Naphazoline Hydrochloride And Pheniramine Maleate

NDC Product Code 0065-0085

NDC 0065-0085-15

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC 0065-0085-42

Package Description: 2 BOTTLE in 1 CARTON > 5 mL in 1 BOTTLE

NDC 0065-0085-52

Package Description: 1 BOTTLE in 1 CARTON > 5 mL in 1 BOTTLE

NDC Product Information

Naphcon A with NDC 0065-0085 is a a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Naphcon A is naphazoline hydrochloride and pheniramine maleate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Naphcon A Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NAPHAZOLINE HYDROCHLORIDE .25 mg/mL
  • PHENIRAMINE MALEATE 3 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA020226 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-08-1994 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Naphcon A Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Purpose

Active ingredientsPurposeNaphazoline hydrochloride 0.025%Redness relieverPheniramine maleate 0.3%Antihistamine

Uses

  • For the temporary relief of redness and itching of the eye(s) due to:ragweed pollengrassanimal dander and hair

Warnings

For external use only

Do Not Use

  • If you are sensitive to any ingredient in this productif this solution changes color or becomes cloudy

Ask A Doctor Before Use If You Have

  • Narrow angle glaucomaheart diseasehigh blood pressuretrouble urinating

When Using This Product

  • Pupils may become enlarged temporarily causing light sensitivityoveruse may cause more eye rednessremove contact lenses before usingto avoid contamination, do not touch tip of container to any surfacereplace cap after each use

Stop Use And Ask A Doctor If

  • You feel eye painchanges in vision occurredness 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 dailychildren 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

* Please review the disclaimer below.