Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

HYDROCORTISONE MAXIMUM STRENGTH (hydrocortisone) Ointment DESCRIPTION Active Ingredient Hydrocortisone 1% Inactive Ingredients aloe barbadensis leaf juice, white petrolatum

INDICATIONS Purpose Anti-itch Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor DOSAGE AND ADMINISTRATION Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor HOW SUPPLIED Other Information store at 20°-25°C (68°-77°F) Active Ingredient Hydrocortisone 1% Inactive Ingredients aloe barbadensis leaf juice, white petrolatum Questions or comments ? 1-800-719-9260 American Sales Company. Revised: Jun 2016

PATIENT INFORMATION For external use only Do not use in the genital area if you have a vaginal discharge. Ask a doctor. for the treatment of diaper rash. Ask a doctor. When using this product avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

SIDE EFFECTS No information provided. Please see WARNINGS Section. DRUG INTERACTIONS No information provided.

WARNINGS For external use only Do not use in the genital area if you have a vaginal discharge. Ask a doctor. for the treatment of diaper rash. Ask a doctor. When using this product avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). PRECAUTIONS No information provided. Please see WARNINGS Section.