ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT- sodium chloride ointment

Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent by

Drug Labeling and Warnings

Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent by is a Otc medication manufactured, distributed, or labeled by Altaire Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Chloride, 50 mg (5%)

Purpose

Hypertonicity Agent

Use

For the temporary relief of corneal edema.

Warnings

For use in the eyes only.

Retain carton for full product drug facts.

Do not use

this product except under the advice and supervision of a doctor.

When using this product

avoid contamination, do not touch tip of container to any surface.

replace cap 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 vision, continued redness or irritation of the eye.

 the condition worsens or persists for more than 72 hours.

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

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

Directions

pull down lower lid of the affected eye(s), apply a small amount (1/4 inch) to the inside of eyelid and apply every 3-4 hours, or as directed by a doctor.

Other information

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

Do not freeze.

Keep tightly closed.

See crimp of tube or box for lot number and expiration date.

Inactive ingredients

Lanolin Alcohol, Mineral Oil, Water for Injection and White Petrolatum.

Questions or comments?

1- 800-258-2471

9 AM-5 PM EST

Monday – Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEALS ON SIDE FLAPS ARE

NOT INTACT AND COMPLETELY LEGIBLE.

Mfd. by:
™ALTAIRE Pharmaceuticals, Inc.
Aquebogue, N.Y. 11931

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in MURO128®*

ISolutions™
Activeyes®
ALTACHLORE
Sodium Chloride 
Hypertonicity
Ophthalmic
Ointment 5%

FOR TEMPORARY RELIEF OF CORNEAL EDEMA

Sterile
NET WT 3.5g (1/8 OZ)

*This product is not manufactured or distributed by Bausch & Lomb, Inc., owner of the registered trademark MURO128®

INGREDIENTS AND APPEARANCE

ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT 
sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59390-184
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOL (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59390-184-50	1 in 1 BOX	03/30/2004
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	03/30/2004

Labeler - Altaire Pharmaceuticals Inc. (786790378)