Triderm

Name: Triderm

Triderm Usage

Take triamcinolone exactly as prescribed. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of triamcinolone at the same time.

This medication comes in several topical forms.

  • Apply the ointment, cream, liquid, or lotion sparingly in a thin film and rub it in gently.
  • To apply the topical spray, shake well and spray on the affected area holding the container about 3 to 6 inches away. Spray for about 2 seconds to cover an area the size of your hand. Avoid inhaling the vapors. If you are spraying near your face, cover your eyes.
  • To apply the paste, press a small amount on the mouth sore without rubbing until a thin film develops. You may need to use more paste if the mouth sore is large. If the mouth sore does not begin to heal within 7 days, call your doctor.
  • The dose and frequency of use of triamcinolone will depend on the condition being treated.

This medication is available in an injectable form to be given directly into a muscle (intramuscular; IM), into a joint (intra-articular) and into the eye (intravitreal) by a healthcare professional.

Triderm Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight, height, or body surface area
  • your age

What is the most important information I should know about Triderm (triamcinolone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with triamcinolone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of triamcinolone topical.

Triamcinolone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I avoid while using Triderm (triamcinolone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use triamcinolone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime. Avoid using other medications on the areas you treat with triamcinolone topical unless your doctor tells you to.

Triderm (triamcinolone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone topical through your skin or gums:

  • blurred vision, or seeing halos around lights;

  • uneven heartbeats;

  • mood changes;

  • sleep problems (insomnia);

  • weight gain, puffiness in your face; or

  • feeling tired.

Less serious side effects may include:

  • skin redness, burning, itching, or peeling;

  • thinning of your skin; or

  • blistering skin; or

  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Proper Use of triamcinolone

This section provides information on the proper use of a number of products that contain triamcinolone. It may not be specific to Triderm. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

If you or your child are using the spray form on or near the face, protect your nose to avoid breathing it in and make sure that your eyes are covered.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the spray on the groin or underarms unless directed to do so by your doctor.

To use:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
  • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
  • If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
  • If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

The spray form is flammable until it dries on the skin. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the aerosol can.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For redness, itching, and swelling of the skin:
    • For topical dosage forms (cream, lotion, and ointment):
      • Adults—Apply to the affected area of the skin two to four times per day.
      • Children—Apply to the affected area of the skin two to four times per day.
    • For topical dosage form (aerosol spray):
      • Adults—Spray to the affected area of the skin three to four times per day.
      • Children—Spray to the affected area of the skin three to four times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Triderm - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.


Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Triderm (Triamcinolone Acetonide Cream USP), 0.1% tube label

NDC 0316-0170-01

Rx Only

Triderm TM

Triamcinolone Acetonide Cream USP, 0.1%

1 oz (28.4 grams)

WARNING: Keep Out Of Reach Of Children.

For external use only.

Not for ophthalmic use.

.

Each gram contains: 1 mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

Usual Dosage: 2 to 3 applications daily. See package insert for full prescribing information.

TO OPEN: Use cap to puncture seal.

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

Store at 20 o-25 oC (68 o-77 oF) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.

See Crimp of tube for Expiration Date and Batch Number.

Manufactured and Distributed by:

Crown Laboratories, Inc., Johnson City, TN 37604

Triderm (Triamcinolone Acetonide Cream USP), 0.5% carton label

NDC 0316-0175-15

Rx Only

Triderm CREAM TM

Triamcinolone Acetonide Cream USP, 0.5%

15 grams

WARNING: Keep out of reach of children

For External Use Only
Not for Ophthalmic Use

USUAL DOSAGE: 2 or 3 applications daily. See package insert for full prescribing information.

See end of carton for batch number and expiration date.

Each gram contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

Directions for puncturing seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal; push down until seal is punctured. Screw cap back on to close

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

Store at 20 o-25 oC (68 o-77 oF) [see USP Controlled Room Temperature]

Avoid excessive heat. Protect from freezing.

Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

Triderm 
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-0175
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
POTASSIUM SORBATE  
WATER  
CETYL PALMITATE  
SORBIC ACID  
PROPYLENE GLYCOL  
MINERAL OIL  
Packaging
# Item Code Package Description
1 NDC:0316-0175-15 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:0316-0175-16 1 JAR in 1 CARTON
2 454 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 03/19/1984
Triderm 
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-0170
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
POTASSIUM SORBATE  
MINERAL OIL  
PROPYLENE GLYCOL  
SORBITOL  
CETYL PALMITATE  
SORBIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0316-0170-01 1 TUBE in 1 CARTON
1 28.4 g in 1 TUBE
2 NDC:0316-0170-03 1 TUBE in 1 CARTON
2 85.2 g in 1 TUBE
3 NDC:0316-0170-30 3 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 03/19/1984
Triderm 
triamcinolone acetonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-0165
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 0.25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
MINERAL OIL  
PROPYLENE GLYCOL  
SORBITOL  
CETYL PALMITATE  
SORBIC ACID  
POTASSIUM SORBATE  
Packaging
# Item Code Package Description
1 NDC:0316-0165-15 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:0316-0165-85 1 TUBE in 1 CARTON
2 85.2 g in 1 TUBE
3 NDC:0316-0165-16 1 JAR in 1 CARTON
3 454 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 03/19/1984
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
Name Address ID/FEI Operations
Crown Laboratories 079035945 manufacture(0316-0170, 0316-0165, 0316-0175)
Revised: 09/2017   Crown Laboratories
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