Hydrocortisone Acetate
Generic: HYDROCORTISONE ACETATE
Basic Information
Manufacturer
Cosette Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RECTAL
FDA Set ID
c84ab549-1d5c-4646-a041-6cb571812ad8
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone Acetate Suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: 1.
Burning 5.
Folliculitis 2.
Itching 6.
Hypopigmentation 3.
Irritation 7.
Allergic Contact Dermatitis 4.
Dryness 8.
Secondary Infection To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Burning 5.
Folliculitis 2.
Itching 6.
Hypopigmentation 3.
Irritation 7.
Allergic Contact Dermatitis 4.
Dryness 8.
Secondary Infection To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .