SODIUM CHLORIDE solution/ drops

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by HUB Pharmaceuticals, Conta Care Ophthalmics and Diagnostics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

• Active Ingredient (each mL contains):

  Purpose

• Sodium Chloride USP 5% w/v (50mg): Hypertonicity agent

Inactive Ingredients:

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

Preservative:

• Methylparaben:

  USP 0.023% w/v

• Propylparaben: USP 0.01% w/v

Directions:

• To open, twist cap clockwise to puncture sterile seal.
• Remove cap.
• Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours as needed or directed by a doctor.

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.

PURPOSE

For the temporaty relief of corneal edema.

WARNINGS

External use only

Do Not Use

• this product except under the advice and supervision of a doctor
• if imprinted seal is broken or missing
• if solution changes color or becomes cloudy

When using this product:

• temporoary burning and iritation upon being instilled into eye may occur
• To avoid contamination, do not touch top of container to any surface
• Replace cap after using, keep tightly closed

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

Stop use and ask a doctor if:

• you experience eye pain, changes in vision, continued redness, or irritation of the eye.
• if the condition worses or persists

USER SAFETY WARNINGS

save box for complete warnings and instructions

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help for contact a Poison Control Center immediately.

STORAGE AND HANDLING

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

Questions?

1-800-Eye-Drop (393-3767)

Monday to Friday 8 AM - 4 PM PST

REPRESENTATIVE PACKAGING:

Sodium Chloride Solution Label

Sodium Chloride Solution Box

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17238-625
Route of Administration	OPHTHALMIC

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	10/15/2014
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/12/2013

Labeler - HUB Pharmaceuticals (611747945)

Establishment
Name	Address	ID/FEI	Business Operations
Conta Care Ophthalmics and Diagnostics		915821765	manufacture(17238-625)