FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Kinray 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.
Otc - Active Ingredient
Active Ingredient Purpose
Hydrocortisone 1% Antipruritic (anti-itch)
Warnings:
For external use only
Purpose
Hydrocortisone is for temporary relief of;
minor skin irritations
Itching and rashes due to;
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry
and for external itching of;
genital
feminine and
anal itching
Indications And Usage
- in the eyes
- longer than 1 week unless directed by a physician
- for diaper rash
- if you have vaginal discharge
- more than the recommended daily dosage unless directed by a doctor
- in the rectum bu using fingers or any other mechanical device or applicator
- For temporary relief of minor skin irritations and external itching.
Stop Use And Ask A Physician If:
- the condition persists or gets worse
- symptoms clear up and occur again within a few days
- you are pregnant or breast feeding
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away.
Dosage And Administration
Adults and children over 2 years of age
- Apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age
- Do not use
- consult a physician Adults
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
- apply externally to the area up to 6 times daily or after each bowel movement
Other Information:
- Store at 20 deg - 25 deg C (68 deg - 77 deg F)
- Avoid excessive heat and humidity
Inactive Ingredients
Inactive Ingredients: Cetostearyl alcohol, glyceryl monostearate, mrthylchloroisothiazolinone, propylene glycol, purified water, stearic acid, triethanolamine, white soft paraffin.
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