Isopto Cetamide (Page 2 of 2)

For Trachoma:

Solution: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED

Solution in 5mL and 15mL plastic DROP-TAINER® Dispensers. Ointment in 3.5g ophthalmic tubes:

5 mL solution — NDC 0998-0522-05

15 mL solution — NDC 0998-0522-15

3.5 g ointment — NDC 0065-0526-35

STORAGE

Solution – Store at 8° — 24°C (46° — 75°F). Protect from light. Do not use if solution is discolored (dark brown). Sulfonamide solutions, on long standing, will darken in color and should be discarded.

Ointment – Store at 8° — 27°C (46°-80°F).

CAUTION: Federal (USA) law prohibits dispensing without prescription.

341035

Rev: January 1995

Alcon®

OPHTHALMIC

ALCON LABORATORIES, INC.

Fort Worth, TX 76134 USA

Printed in USA

ISOPTO CETAMIDE sulfacetamide sodium solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0998-0522 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide 150 mg in 1 mL

Inactive Ingredients Ingredient Name Strength methylparaben propylparaben hydroxypropyl methylcellulose 2910 sodium thiosulfate dibasic sodium phosphate monobasic sodium phosphate water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0998-0522-05 5 mL (5 MILLILITER) in 1 BOTTLE, PLASTIC None 2 NDC:0998-0522-15 15 mL (15 MILLILITER) in 1 BOTTLE, PLASTIC None

CETAMIDE sulfacetamide sodium ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0526 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide 100 mg in 1 g

Inactive Ingredients Ingredient Name Strength methylparaben propylparaben white petrolatum anhydrous liquid lanolin mineral oil

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0065-0526-35 3.5 g (3.5 GRAM) in 1 TUBE None

Labeler — Alcon

Revised: 11/2006 Alcon