NDC 72103-333 Nasal Decongestant

Oxymetazoline Hydrochoride

NDC Product Code 72103-333

NDC 72103-333-15

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 10 mL in 1 BOTTLE, DROPPER

NDC Product Information

Nasal Decongestant with NDC 72103-333 is a a human over the counter drug product labeled by The Ibn Sina Pharmaceutical Industry Ltd.. The generic name of Nasal Decongestant is oxymetazoline hydrochoride. The product's dosage form is solution/ drops and is administered via nasal form.

Labeler Name: The Ibn Sina Pharmaceutical Industry Ltd.

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.

Nasal Decongestant 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/100mL

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)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
  • POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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: The Ibn Sina Pharmaceutical Industry Ltd.
Labeler Code: 72103
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: 03-12-2019 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.

Nasal Decongestant Product Label Images

Nasal Decongestant 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

Other

Drug Facts

Manufactured by:The
IBN SINA Pharmaceutical Industry Ltd.
Holding # A-80, Ward # 9, Shafipur, Kaliakoir,Gazipur-1751, Bangladeshwww.ibnsinapharma.comProduct of Bangladesh

Otc - Active Ingredient

Active ingredientOxymetazoline hydrochloride 0.05%

Otc - Purpose

PurposeNasal decongestant

Indications & Usage

  • Usestemporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies

Warnings

Warnings

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland

Otc - When Using

  • When using this productdo not exceed recommended dosagedo not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsenit may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal dischargeuse of this container by more than one person may spread infection

Otc - Stop Use

Stop use and ask a doctor if symptoms persist

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

  • DirectionsAdults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period.Children under 6 years of age: consult a doctor.

Storage And Handling

  • Other informationstore between 15° to 30°C (59° to 86°F)TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON BOTTLE OR DROPPER TIP IS LOOSE, BROKEN OR MISSING

Inactive Ingredient

Inactive ingredientsbenzalkonium chloride, edetate disodium, glycerin, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic dihydrate, water.

Otc - Questions

Questions?1-833-IBN-SINA (1-833-426-7462)

* Please review the disclaimer below.