TL TRISEB CREAM description, usages, side effects, indications, overdosage, supplying and lots more!

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TL TRISEB CREAM

TRIGEN Laboratories, Inc.

TL TRISEB


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

TL TRISEB CREAM

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

TL TRISEB CREAM

TL TRISEB CREAM

CREAM

Product Information

Product Type Prescription medical device label Item Code (Source) NDC:13811-587
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
propylene glycol Propylene Glycol
LACTIC ACID
CITRIC ACID MONOHYDRATE
Malic Acid
ALLANTOIN
ASCORBYL TETRAISOPALMITATE
LEVOMENOL
BUTYLENE GLYCOL
SHEA BUTTER
white wax
EDETATE DISODIUM
ETHYLHEXYL PALMITATE
Glycyrrhizin
HYDROGENATED CASTOR OIL
Isohexadecane
MAGNESIUM STEARATE
MAGNESIUM SULFATE
PEG-30 DIPOLYHYDROXYSTEARATE
PENTYLENE GLYCOL
PIROCTONE OLAMINE
POLYGLYCEROL POLYRICINOLEIC ACID
PROPYL GALLATE
water
TELMESTEINE
.ALPHA.-TOCOPHEROL ACETATE
WINE GRAPE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 TUBE
2 NDC:13811-587-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
K K121134 2011-12-01


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