TL TRISEB CREAM by Trigen Laboratories, Inc. TL TRISEB

TL TRISEB CREAM by

Drug Labeling and Warnings

TL TRISEB CREAM by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TL TRISEB CREAM- dressing, wound, drug   cream 
Trigen Laboratories, Inc.

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TL TRISEB

Product Description

TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.

INDICATIONS FOR USE

Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

DIRECTIONS FOR USE

Apply TL Triseb Cream to affected skin areas 2 to 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover TL Triseb Cream with a dressing of choice.

INGREDIENTS

TL Triseb Cream in comprised of Acifructol Complex, Allantoin, Ascorbyl Tetraisopalmitate, Bisabolol, Butylene Glycol, Butyrospermum Parkii, Cera Alba, Disodium EDTA, Ethylhexyl Palmitate, Glycyrrhetinic Acid, Hydrogenated Castor Oil, Isohexadecane, Magnesium Stearate, Magnesium Sulfate, PEG-30 Dipolyhydroxystearate, Pentylene Glycol, Piroctone Olamine, Polyglyceryl-6 Polyricinoleate, Propyl Gallate, Purified Water, Telmesteine, Tocopheryl Acetate, and Vitis Vinifera (Grape) Fruit Extract.

CAUTION

The use of TL Triseb Cream is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients. TL Triseb Cream does not contain milk, wheat, peanut or animal derivatives. TL Triseb Cream does contain shea butter (Butyrospermum parkii), a derivative of the shea nut oil (not peanut oil). Patients with a known allergy to nut oils should consult their physician before using this topical preparation.

HOW SUPPLIED

30 gram tube, Product Code: 13811-587-30

TO OPEN: Puncture seal with pointed end of cap.

IMPORTANT:

The opening of this product is covered by a foil seal.

Do not use if seal has been punctured or is not visible.

STORAGE

Store at controlled room temperature 68° - 77° F (20° - 25° C), excursions permitted between 59° - 86° F. Do not freeze.



See crimp for lot number and expiration date.

Manufactured for

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 Gram Carton Label

13811-587-30

Rx Only

TL TRISEB CREAM

For Topical Dermatological Use Only

TRIGEN LABORATORES

Net Wt. 30g

30 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 Gram Tube Label

13811-587-30

Rx Only

TL TRISEB CREAM

For Topical Dermatological Use Only

TRIGEN LABORATORES

Net Wt. 30g

30 g Carton

TL TRISEB CREAM 
dressing, wound, drug cream
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:13811-587
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRMALIC ACID (UNII: 817L1N4CKP)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRWHITE WAX (UNII: 7G1J5DA97F)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRGLYCYRRHIZIN (UNII: 6FO62043WK)  
INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRMAGNESIUM STEARATE (UNII: 70097M6I30)  
INGRMAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
INGRPEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRPIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
INGRPOLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)  
INGRPROPYL GALLATE (UNII: 8D4SNN7V92)  
INGRWATER (UNII: 059QF0KO0R)  
INGRTELMESTEINE (UNII: 124I3FE35T)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWINE GRAPE (UNII: 3GOV20705G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-587-301 in 1 CARTON
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK12113412/01/201102/28/2016
Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 3/2014