FDA.reportPublic FDA data

IBN OXYMETAZOLINE NASAL SOLUTION

Manufacturer
THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.
Effective date
2019-03-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:45

Label at a glance#

ProductNasal Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure16 sections

Storage and handling

Other information store 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

  • Adults 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 SECTION

Other information

  • store 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 SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

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

SPL UNCLASSIFIED SECTION

Manufactured by:

The IBN SINA Pharmaceutical Industry Ltd.

Holding # A-80, Ward # 9, Shafipur, Kaliakoir,

Gazipur-1751, Bangladesh

www.ibnsinapharma.com

Product of Bangladesh

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72103-333-15

NASAL DECONGESTANT

Oxymetazoline HCL 0.05% Nasal Solution

Helps relieve congestion

0.34 FL OZ (10 mL)

Oxymetazoline IC 05.03.19Oxymetazoline IC 05.03.19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000987oxymetazoline HCl 0.05 % Nasal SolutionPSN2
1000987oxymetazoline hydrochloride 0.5 MG/ML Nasal SolutionSCD2
1000987oxymetazoline hydrochloride 0.05 % Nasal DropsSY2
1000987oxymetazoline hydrochloride 0.05 % Nasal SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72103-333-152021-01-29C16284748780-1ba0f9c33-3a29-a910-e053-dadaa90a0b85IBN OXYMETAZOLINE NASAL SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72103-333-15Nasal Decongestant10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
72103-333-15Nasal Decongestant1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72103-333NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHORIDE) SOLUTION/ DROPS [THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.]2Legacy NDC, 2 package rows20190312_711f099d-0690-5d03-e053-2a95a90a1755.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72103-33372103-333-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
83e3f918-1d2c-1b93-e053-2a91aa0a8510711f099d-0690-5d03-e053-2a95a90a17552019-03-12WarningsExact identifier
spl id: 83e3f918-1d2c-1b93-e053-2a91aa0a8510
spl set id: 711f099d-0690-5d03-e053-2a95a90a1755

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.