ne acetonide injectable suspension)
40 mg/mL
Preservative Free
Store at 4°-25°C (39°-77°F)
Do not freeze.
Rx Only
Single Use
ALCON®
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134-2099
H11231-0908
LOT:
EXP:
label
INGREDIENTS AND APPEARANCE
TRIESENCE
triamcinolone acetonide injection, suspension
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0543
Route of Administration OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0065-0543-01 1 in 1 CARTON 11/15/2007
1 1 in 1 BLISTER PACK
1 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022048 11/15/2007
LABELER - ALCON LABORATORIES, INC. (008018525)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Pharmacia and Upjohn Company LLC 618054084 API MANUFACTURE(0065-0543) , ANALYSIS(0065-0543)
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