FDA Label for Avedana Hydrocortisone Maximum Strength

View Indications, Usage & Precautions

Avedana Hydrocortisone Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Unipack Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Hydrocortisone, USP 1%


Purpose



Anti-itch


Uses



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


Warnings



For external use only


Do Not Use



for external feminine itching if you have a vaginal discharge.  Consult a doctor.

for the treatment of diaper rash.  Consult a doctor.


When Using This Product



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


Stop Use And Ask A Doctor If



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


Keep Out Of Reach Of Children.



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


Directions



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 applicaion of this product.

Children under 12 years of age: consult a doctor.


Other Information



Storage temperature: not to exceed 30oC (86oF).

Before using any medication, read all label directions.  Keep carton, it contains important information.


Inactive Ingredients



mineral oil, white petrolatum


* Please review the disclaimer below.