NDC 43136-105 Avon Hexashield Congestion Relief Original

Oxymetazoline Hydrochloride

NDC Product Code 43136-105

NDC Code: 43136-105

Proprietary Name: Avon Hexashield Congestion Relief Original What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Oxymetazoline Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43136 - Tai Guk Pharm. Co., Ltd.
    • 43136-105 - Avon Hexashield Congestion Relief

NDC 43136-105-01

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

NDC Product Information

Avon Hexashield Congestion Relief Original with NDC 43136-105 is a a human over the counter drug product labeled by Tai Guk Pharm. Co., Ltd.. The generic name of Avon Hexashield Congestion Relief Original is oxymetazoline hydrochloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Tai Guk Pharm. Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Avon Hexashield Congestion Relief Original 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.

  • OXYMETAZOLINE HYDROCHLORIDE .05 g/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.

  • WATER (UNII: 059QF0KO0R)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • EDETIC ACID (UNII: 9G34HU7RV0)

Administration Route(s)

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

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

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

Labeler Name: Tai Guk Pharm. Co., Ltd.
Labeler Code: 43136
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-31-2019 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.

Information for Patients

Oxymetazoline Nasal Spray

Oxymetazoline Nasal Spray is pronounced as (ok'' see met az' oh leen)

Why is oxymetazoline nasal spray medication prescribed?
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymeta...
[Read More]

* Please review the disclaimer below.

Avon Hexashield Congestion Relief Original Product Label Images

Avon Hexashield Congestion Relief Original 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

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

  • Temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergiestemporarily relieves sinus congestion and pressureshrinks swollen nasal membranes so you can breathe more freely

Warnings

For external use only.

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurediabetesthyroid diseasetrouble urinating due to an enlarged prostate gland

When Using This Product

  • Do not use more than directeddo not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.use of this container by more than one person may spread infection.

Stop Use And Ask A Doctor If :

  • Symptoms persist.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age: ask a doctor: Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

Other Information

  • Store between 20° to 25°C (68° to 77°F)retain carton for future reference on full labeling

Inactive Ingredients

Benzalkonium chloride, edetate disodium, polyethylene glycol 400, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasi dihydrate, water

* Please review the disclaimer below.

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