FDA.reportPublic FDA data

Altachlore Sodium Chloride Hypertonicity Ophthalmic Solution

Manufacturer
Altaire Pharmaceuticals Inc.
Effective date
2023-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:17

Label at a glance#

ProductAltachlore Sodium Chloride Hypertonicity
Active ingredientSODIUM CHLORIDE
Label structure10 sections

Dosage and administration

instill 1 or 2 drops in the affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

iSolutions

ActivEyes

Altachlore5% Solution

Sodium Chloride Hypertonicity

OphthalmicSolution5%

15mL

NDC 59390-183-13

Drug Facts

Activeingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 5%

Purpose

OTC - PURPOSE SECTION

Hypertonicity Agent

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of corneal edema.

Warnings

WARNINGS SECTION

For use in the eyesonly

Save box for complete information

Do not use

OTC - DO NOT USE SECTION

  • except under the advice and supervision of a doctor.
  • if solution changes color or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • keep tightly closed.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap immediately after each use.
  • this product may cause temporary burning and irritation on being instilled into the eye.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain.
  • changes in your vision occur.
  • continued redness or irritation of the eye persists.
  • condition worsens or persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 or 2 drops in the affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Other information

OTHER SAFETY INFORMATION

  • replace cap after using and keep tightly closed.
  • store at 15° to 30°C (59° to 86°F).
  • remove contact lenses before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric Acid, Hypromellose, Methylparaben, Propylene Glycol, Proplyparaben, Sodium Borate, and Water for injection. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH.

Questions?

OTC - QUESTIONS SECTION

  • 1 (800) 258-2471
  • 9am– 5pm EST Monday - Friday

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iSolutionsActivEyesAltachlore5% SolutionSodium ChlorideHypertonicity OphthalmicSolution5%Sterile
15mLNET WT (1/2 FL OZ)






PRINCIPAL DISPLAY PANEL iSolutions ActivEyes Altachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5% Sterile 15mL NET WT (1/2 FL OZ)PRINCIPAL DISPLAY PANEL iSolutions ActivEyes Altachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5% Sterile 15mL NET WT (1/2 FL OZ)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
730780sodium chloride 5 % Ophthalmic SolutionPSN4
730780sodium chloride 0.854 MEQ/ML Ophthalmic SolutionSCD4
730780NaCl 0.854 MEQ/ML Ophthalmic SolutionSY4
730780NaCl 5 % Ophthalmic SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-183-13Altachlore Sodium Chloride Hypertonicity15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
59390-183-13Altachlore Sodium Chloride Hypertonicity1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-183ALTACHLORE SODIUM CHLORIDE HYPERTONICITY (SODIUM CHLORIDE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20231214_dc0d94d8-4475-4956-8ded-bdb9496074e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-183-13ML - Milliliter59390-18321fff4a4-98da-463c-9bfb-5a116915795a12018-09-05

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
59390-18359390-183-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

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
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
ndc (package): 59390-183-13
ndc (product): 59390-183
ndc11 (package): 59390018313
spl id: 0c0e9c0d-61f5-e63b-e063-6294a90ac0d9
spl set id: dc0d94d8-4475-4956-8ded-bdb9496074e4

Reported adverse events (FAERS/openFDA)#

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