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.

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 as a Whole) (2%).

Skin irritation, eczema, pruritus, application site reaction, rash, rash maculopapular, and dry skin were all reported at incidences of approximately 1%.

To report SUSPECTED ADVERSE REACTIONS , contact Encube Ethicals Private Limited al 1-833-285-4151 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.