Hydrocortisone

Actavis Mid Atlantic LLC

FULL PRESCRIBING INFORMATION

Hydrocortisone, USP 1%

Anti-itch

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• jewelry
• detergents
• cosmetics
• psoriasis
• seborrheic dermatitis
• for external genital, feminine and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

For external use only

• for external feminine itching if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

• avoid contact with the eyes
• do not begin the use of any other hydrocortisone product unless directed by a doctor
• for external anal itching:

• do not use more than directed unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

• symptoms last for more than 7 days
• the condition gets worse
• symptoms clear up and occur again in a few days
• rectal bleeding occurs, consult doctor promptly

If swallowed, get medical help or contact a Poison Control Center right away.

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, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

• Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
• Before using any medication, read all label directions.  Keep carton, it contains important information.

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Actavis

NDC 0472-0343-56

Anti-itch Cream

Hydrocortisone CREAM USP 1%

Compare to the active ingredient in Cortaid ^® Maximum Strength Cream*

MAXIMUM STRENGTH CREAM

For the Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation and Rashes Due to:

• Poison Ivy, Oak, Sumac
• Eczema
• Insect Bites
• Seborrheic Dermatitis
• External Genital, Feminine or Anal Itch

NET WT 1 OZ (28 g)

03430311F1 VC110436