Indications and uses
VA SO CON REGULAR is indicated for use as a topical ocular vasoconstrictor.
Vasocon - CIBA Vision
- Manufacturer
- CIBA Vision
- Effective date
- 2006-08-31
- Label type
- HUMAN PRESCRIPTION DRUG LABELING
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:06:44
Label at a glance#
ProductVasocon
Label structure10 sections
Dosage and administration
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
VASOCON REGULAR
NAPHAZOLINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1%
DESCRIPTION
Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:
Chemical Name:
2-(1-naphthylmethyl)-2-imidazoline monohydrochloride
VASOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL naphazoline hydrochloride in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.
CLINICAL PHARMACOLOGY
Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphalozine belongs to the imidazoline class of sympathomimetics.
INDICATIONS AND USAGE
VASOCON REGULAR is indicated for use as a topical ocular vasoconstrictor.
CONTRAINDICATIONS
Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.
WARNINGS
Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
PRECAUTIONS
General
Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.
Patient Information
Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring, or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.
To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.
Drug Interactions
Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. (See WARNINGS).
Pregnancy Category C
Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.
Nursing Mothers
If is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.
ADVERSE REACTIONS
Ocular
Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.
Systemic
Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.
DOSAGE AND ADMINISTRATION
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
HOW SUPPLIED
VASOCON REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).
CAUTION: Federal law prohibits dispensing without prescription.
Mfd. by OMJ Pharmaceuticals, Inc.,
San Germán, P.R., 00683 for:
CIBA Vision
Ophthalmics®
___________________
Atlanta, Georgia 30155
6072-A
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046272 | naphazoline HCl 0.1 % Ophthalmic Solution | PSN | 1 |
| 1046291 | Vasocon 0.1 % Ophthalmic Solution | PSN | 1 |
| 1046291 | naphazoline hydrochloride 1 MG/ML Ophthalmic Solution [Vasocon] | SBD | 1 |
| 1046272 | naphazoline hydrochloride 1 MG/ML Ophthalmic Solution | SCD | 1 |
| 1046272 | naphazoline hydrochloride 0.1 % Ophthalmic Solution | SY | 1 |
| 1046291 | Vasocon 0.1 % Ophthalmic Solution | SY | 1 |
| 1046291 | Vasocon 1 MG/ML Ophthalmic Solution | SY | 1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58768-844-15 | Vasocon | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| naphazoline hydrochloride | ACTIVE INGREDIENT | MZ1131787D | 1 | |
| naphazoline | ACTIVE MOIETY | H231GF11BV | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | 1 | ||
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| polyethylene glycol 8000 | INACTIVE INGREDIENT | 1 | ||
| polyvinyl alcohol | INACTIVE INGREDIENT | 1 | ||
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Vasocon
- naphazoline hydrochloride
- naphazoline
- benzalkonium chloride
- edetate disodium
- hydrochloric acid
- polyethylene glycol 8000
- polyvinyl alcohol
- water
- sodium chloride
- sodium hydroxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58768-844 | 58768-844-15 |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / PERIDURAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / EPIDURAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, EXTENDED RELEASE / ORAL | 13 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | OINTMENT / TOPICAL | NA | ||
| polyethylene glycol 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 14 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRATHECAL | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / EPIDURAL | 3535 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / INTRAVENOUS | 0.03 %w/v | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRAMUSCULAR | 1 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PERIDURAL | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / TOPICAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 0.35 %w/v | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAPERITONEAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVENOUS | 2.78 %w/v | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / OPHTHALMIC | 1.4 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SHAMPOO / TOPICAL | 3 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SPRAY / NASAL | 30 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRALESIONAL | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / ENDOTRACHEAL | 68 mg | ||
| polyethylene glycol 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SPRAY / NASAL | 10 ml | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRAMUSCULAR | 9 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | CREAM / TOPICAL | 38 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAOCULAR | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / EPIDURAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRALESIONAL | ADJ PH | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | GEL / OPHTHALMIC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVENOUS | 28773 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVENOUS | 0.9 %w/v | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | TABLET / ORAL | 2.32 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0F25812F-96AB-44F4-BACF-2EB012CBDDC7 | 0F25812F-96AB-44F4-BACF-2EB012CBDDC7 | 2006-08-31 | Warnings, Adverse reactions | 0F25812F-96AB-44F4-BACF-2EB012CBDDC7 0F25812F-96AB-44F4-BACF-2EB012CBDDC7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.