Ala Cort 1oz Label - ../images/alacort_P650201.jpg
Ala-Cort Hydrocortisone Cream USP, 1%
Each g contains 10mg Hydrocortisone USP in a cream base consisting of Purified Water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, sorbic acid
Distributed by Del-Ray Dermatologicals
Manufactured by Crown Laboratories, Inc
Johnson City, TN 37604
Usual dosage: Apply as a thin film to the affected areas 2 to 4 time daily. See insert.
See crimp of tube for Expiration Date and Batch Number
Caution: Federal law prohibits dispensing without prescription
For External Use Only.
Not for Ophthalmic Use.
Keep Out Of Reach Of Children
Ala Cort Patient Package Insert
Ala Cort Product Package Insert
Ala Cort Prescribing Information
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anit-inflammitory and antipruritic agents. Hydrocortisone is a
member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11,
17, 21-trihydroxy, (IIβ). Its structural formula is:
Each gram of ALA CORT (Hydrocortisone Cream USP) 1% contains 10 mg
hydrocortisone USP in a creambase consisting of purified water, cetyl alcohol,
glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, and sorbic acid
Topical corticosteroids share
anti-inflammatory, antipruritic and vasoconstrictive actions.
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
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).
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
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
Hydrocortisone cream is indicated for the
relief of the inflammatory and pruritic manifestations of
Hydrocortisone cream is contraindicated in those
patients with a history of hypersensitivity to any of the components of the
Systemic absorption of topical
corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and
glucosuria in some patients.
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 a 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. If HPA axis suppression is noted, an
attempt should be made to withdraw the drug, to reduce the frequency of
application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid
withdrawal may occur, requiring supplemental systemic
Children may absorb proportionally larger amounts of topical
corticosteroids and thus be more susceptible to systemic toxicity (See
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.
Information for the Patient
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 prescribed.
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.
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.
The following tests may be helpful in evaluating
the HPA axis suppression:
∙ Urinary free cortisol test
∙ ACTH stimulation
Carinogensis, Mutagenesis, and Impairment of Fertility
animal studies have not been performed to evaluate the carcinogenic potential or
the effect on fertility of topical corticosteroids.
determine mutagenicity with prednisolone and hydrocortisone have revealed
Pregnancy 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 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.
Hypothalamic-pituitary-adrenaI (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
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. These reactions are listed in an approximate
decreasing order of
∙Maceration of the
Topically applied corticosteroids can be absorbed in
sufficient amounts to produce systems effects (See PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally
applied to the affected area as a thin film from two to four times daily
depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or
recalcitrant conditions. If an infection develops, the use of occlusive
dressings should be discontinued and appropriate antimicrobial therapy
Ala Cort (Hydrocortisone Cream USP) 1% is supplied in 3 ounce (85.2g) and 1 ounce (28.4g) tubes
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT
CROWN LABORATORIES, INC.
For DEL-RAY DERMATOLOGICALS
349 Lafe Cox Drive
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