FDA Label for Hydrocortisone Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- AVEDANA ® MAXIMUM STRENGTH HYDROCORTISONE OINTMENT | 1OZ TUBE LABEL
- AVEDANA ® MAXIMUM STRENGTH HYDROCORTISONE OINTMENT | 1OZ CARTON LABEL
Hydrocortisone Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Unipack, Inc.. 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.
- do not use, consult a doctor.
- consult a doctor.
Children under 2 years of age
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:
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
Avedana ® Maximum Strength Hydrocortisone Ointment | 1Oz Tube Label
Avedana ® Maximum Strength Hydrocortisone Ointment | 1Oz Carton Label
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