Drugplain

hydrocortisone valerate cream 2 mg/g

hydrocortisone valerate cream · CREAM · Encube Ethicals, Inc.

No Recall HistoryCurrently in Shortage
Plain English

hydrocortisone valerate cream is a cream containing hydrocortisone valerate cream at 2 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..

Key Facts

Brand Name
hydrocortisone valerate cream
Generic Name
hydrocortisone valerate cream
NDC Code (Product)
21922-007
Manufacturer
Encube Ethicals, Inc.
Strength
2 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA211047
Marketing Start
12/31/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Dosage & Administration

DOSAGE AND ADMINISTRATION Hydrocortisone valerate cream USP, 0.2% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Hydrocortisone valerate cream USP, 0.2% should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate cream USP, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

Contraindications

CONTRAINDICATIONS Hydrocortisone valerate cream USP, 0.2% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Adverse Reactions

ADVERSE REACTIONS Hydrocortisone Valerate Cream USP, 0.2% The following local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These 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. In controlled clinical studies involving pediatric patients one month to 2 years of age (n=29), the incidence of adverse experiences, regardless of relationship to the use of hydrocortisone valerate cream USP, 0.2%, was approximately 21%. Reported reactions included stinging (10%), eczema (7%), fungal infection (3%), and gastrointestinal disorder (3%). In controlled clinical studies involving pediatric patients 2 to 12 years of age (n=153), the incidence of adverse experiences, regardless of relationship to the use of hydrocortisone valerate cream USP, 0.2%, was approximately 10%. Reported reactions included stinging (3%), burning skin (2%), infection (Body a

Frequently Asked Questions

What is hydrocortisone valerate cream used for?

hydrocortisone valerate cream contains hydrocortisone valerate cream. It is a cream taken topical. Consult your doctor for specific uses.

Is hydrocortisone valerate cream a controlled substance?

hydrocortisone valerate cream is not classified as a controlled substance by the DEA.

What is the generic name for hydrocortisone valerate cream?

The generic name for hydrocortisone valerate cream is hydrocortisone valerate cream. There are no other listed brand versions of hydrocortisone valerate cream.

What is the NDC code for hydrocortisone valerate cream 2 mg/g?

The NDC (National Drug Code) for hydrocortisone valerate cream 2 mg/g is 21922-007, listed by Encube Ethicals, Inc..

Product NDC

21922-007

Package NDC

21922-007-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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