Label: ALTACHLORE SODIUM CHLORIDE HYPERTONICITY- sodium chloride solution/ drops

  • NDC Code(s): 59390-183-13
  • Packager: Altaire Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • SPL UNCLASSIFIED SECTION

    iSolutions

    ActivEyes

    Altachlore5% Solution

    Sodium Chloride Hypertonicity

    OphthalmicSolution5%

    15mL

    NDC 59390-183-13

    Drug Facts

  • Activeingredient

    Sodium Chloride 5%

  • Purpose

    Hypertonicity Agent

  • Use

    • For the temporary relief of corneal edema.
  • Warnings

    For use in the eyesonly

    Save box for complete information

    Do not use

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

    When using this product

    • 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

    • 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.

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

  • Directions

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

    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?

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

  • INGREDIENTS AND APPEARANCE
    ALTACHLORE SODIUM CHLORIDE HYPERTONICITY 
    sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-183
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-183-131 in 1 CARTON09/24/2002
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01809/24/2002
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceuticals Inc.786790378manufacture(59390-183)