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 Dynarex Corporation. 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
For temporary relief of:
- minor skin irritations
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- genital
- feminine and
- anal itching
Itches and rashes due to:
and for external itching of:
Otc - Do Not Use
Do Not Use:
- in the eyes
- longer than 1 week unless directed by a physician
- for diaper rash
- if you have vaginal discharge
- more than recommended daily dosage unless directed by a doctor
- in the rectum using fingers or any other mechanical device or applicator
Otc - Stop Use
Stop use and ask a physician if:
- the condition persists or gets worse
- symptoms clear up and appear again within a few days
- you are pregnant or breast feeding
Otc - Keep Out Of Reach Of Children
Keep Out Of Reach of Children
- if swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
Adults and children 2 years of age:
- apply evenly to affected area no more than 3 or 4 times daily.
- Do not use
- consult a physician
- 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
Children under 2 years of age:
Adults:
Inactive Ingredient
Inactive ingredients:
Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)
Other
Other information:
- store at 20 deg. to 25 deg. C (68 deg. - 77 deg. F)
- avoid excessive heat and humidity
Indications & Usage
For temporary relief of minor skin irritations and external itching.
Package Label.Principal Display Panel
Principal Display Panel
Dynarex Hydrocortisone Items 1137 and 1139
Hydro1139.jpg
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