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

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