TRI-LUMA (Page 5 of 5)

30g Carton Label

30g-carton-image
(click image for full-size original)

Tri-Luma® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05%
MUST BE REFRIGERATED
NDC 0299-5950-30
Rx Only

For Topical Use Only. Not for Ophthalmic Use.
Usual dosage: Apply a thin film affected areas once daily at night. See package insert for complete prescribing information.
Each gram contains: Active: fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
Storage: Store in a refrigerator, 2° to 8° C (36° to 46° F). Protect from freezing.
See carton closure for lot number and expiration date.
www.triluma.com

Marketed by:
GALDERMA LABORATORIES, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners.
P51399-5MUST BE REFRIGERATED

TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5950
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.1 mg in 1 g
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
TRETINOIN (TRETINOIN) TRETINOIN 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CETYL ALCOHOL
ANHYDROUS CITRIC ACID
GLYCERIN
GLYCERYL MONOSTEARATE
MAGNESIUM ALUMINUM SILICATE
METHYL GLUCETH-10
METHYLPARABEN
PEG-100 STEARATE
PROPYLPARABEN
WATER
SODIUM METABISULFITE
STEARIC ACID
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5950-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0299-5950-30)
2 NDC:0299-5950-02 1 TUBE in 1 BLISTER PACK contains a TUBE
2 3 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5950-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021112 01/18/2002
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
Hill Dermaceuticals, Inc. 098366990 manufacture (0299-5950)
Establishment
Name Address ID/FEI Operations
G Production, Inc. 251676961 manufacture (0299-5950)

Revised: 03/2014 Galderma Laboratories, L.P.

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