SODIUM CHLORIDE- sodium chloride solution/ drops 
HUB Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sodium Chloride 5% Solution USP (Sterile)

Drug Facts:

Active Ingredien

(each mL contains)

Purpose

Sodium Chloride USP

5% w/v (50mg)

Eye Lubricant

Preservative:

Methylparaben

USP 0.023% w/v

Propylparaben USP 0.01% w/v

Inactive Ingredients:

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

Directions:

Dosage & Administration:

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

Indications:

For the temporaty relief of corneal edema.

For the temporaty relief of corneal edema.

When using this product:

In case of accidental ingestion, seek professional help or contact a Poision Control Center immediately.

Stop use and ask a doctor if:

DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN, OR MISSING AND IF IMPRINTED DEALS ON TOP AND BOTTOM FLAPS ARE NOT INTACT AND CCOMPLETELY LEGIBLE.

FOR USE IN EYES ONLY.

DO NOT DISCARD BOX. SAVE FOR COMPLETE WARNINGS AND INSTRUCTIONS.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Store at room temperature 15°-30°C (59°-86°F).

REPRESENTATIVE PACKAGING:

HUB_NaCL Label

Sodium Chloride Solution Label

HUB_NaCL Box

Sodium Chloride SolutionBox

SODIUM CHLORIDE 
sodium chloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17238-625
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BORIC ACID (UNII: R57ZHV85D4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17238-625-15 1 in 1 BOX
1 15 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/12/2013
Labeler - HUB Pharmaceuticals (611747945)
Establishment
Name Address ID/FEI Business Operations
Conta Care Ophthalmics and Diagnostics 915821765 manufacture(17238-625)

Revised: 9/2013
Document Id: 416e4093-6b7e-4946-9acf-d1deb1fa2fba
Set id: cd8cb7a8-084d-4a1b-9302-911f7a6330c8
Version: 1
Effective Time: 20130912
 
HUB Pharmaceuticals