TRIAMCINOLONE ACETONIDE - triamcinolone acetonide ointment
G&W Laboratories, Inc.
Triamcinolone Acetonide Ointment, USP 0.5%
For External Use Only
Not for Ophthalmic Use
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory
and antipruritic agents.The steroids in this class include triamcinolone acetonide. Triamcinolone
acetonide is designated chemically as 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-
dione cyclic 16,17-acetal with acetone. The structural formula of triamcinolone acetonide is as
Each gram of Triamcinolone Acetonide Ointment, USP 0.5% provides 5 mg triamcinolone acetonide in
an ointment base of light mineral oil and white petrolatum.
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.
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.
INDICATIONS AND USAGE
Triamcinolone Acetonide Ointment, USP 0.5% is indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of
the components of the preparations.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some
Conditions which augment systemic absorption include the application of the more potent steroids, use
over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area
or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression
by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal
homeostatis.If HPA axis suppression or elevation of the body temperature occurs, an attempt should be
made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or
use a sequential approach when utilizing the occlusive technique.
Recovery of HPA axis function and thermal homeostatis are generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur,
requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity
reaction to a particular occlusive dressing material or adhesive and a substitute material may be
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more
susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent
should be instituted. If a favorable response does not occur promptly, the corticosteroid should be
discontinued until the infection has been adequately controlled.
These preparations are not for ophthalmic use.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact
with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive
unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a
child being treated in the diaper area, as these garments may constitute occlusive dressings.
A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect
on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.
Pregnancy: Teratogenic Effects
Category C. Corticosteroids are generally teratogenic in laboratory animals when administered
systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be
teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled
studies in pregnant women on the teratogenic effects from topically applied corticosteroids. Therefore,
topical corticosteroids should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in
large amounts, or for prolonged periods of time.
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.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA
axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface
area to body weight ratio.
HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in
children receiving topical corticosteroids. Manifestations of adrenal suppression in children include
linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to
ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches,
and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible
with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and
development of children.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may
occur more frequently with the use of occlusive dressings (reactions are listed in an approximate
decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis,
acneiform eruptions,hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the
skin, secondary infection, skin atrophy, striae, and miliaria.
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-
922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects
(see PRECAUTIONS, General).
DOSAGE AND ADMINISTRATION
Apply a thin film of the 0.5% Triamcinolone Acetonide Ointment, as appropriate, to the affected area 2
to 3 times daily.
Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If
needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth
before the nonporous film is applied or by briefly wetting the affected area with water immediately
prior to applying the medication.The frequency of changing dressings is best determined on an
individual basis. It may be convenient to applyTriamcinolone Acetonide Ointment under an occlusive
dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When
utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion,
during the day. Reapplication is essential at each dressing change.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate
antimicrobial therapy instituted.
Triamcinolone Acetonide Ointment, USP 0.5% is available as follows:
15 g tube (NDC 0713-0679-15)
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
PRINCIPAL DISPLAY PANEL
triamcinolone acetonide ointment
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:0 713-0 6 79
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
Tria mcino lo ne Aceto nide (UNII: F446 C59 7KA) (Triamcino lo ne Aceto nide -
UNII:F446 C59 7KA)
Tria mc ino lo ne
Ac e to nide
5 mg in 1 g
Stre ng th
Lig ht Minera l O il (UNII: N6 K578 7QVP)
G&W Laboratories, Inc.
Petro la tum (UNII: 4T6 H12BN9 U)
Marketing Start Date
Marketing End Date
NDC:0 713-0 6 79 -15
1 in 1 CARTON
10 /31/20 17
15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA20 8 9 25
10 /31/20 17
G&W Laboratories, Inc. (001271188)
G&W Laboratories, Inc. (001271188)
Ad d re s s
Busine ss Ope rations
G&W Labo rato ries, Inc.
0 0 127118 8
ma nufa c ture (0 713-0 6 79 )