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Drug Facts
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
Manufactured in India
MH/DRUGS/28-KD/503
Hydrocortisone Cream
FDA Label NDC 68071-5305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals, Inc. for the product Hydrocortisone (NDC 68071-5305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
- temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- temporarily relieves external anal and genital 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
- in the genital area 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 eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
- rectal bleeding occurs
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.
Directions
- for itching of skin irritation, inflammation, and rashes
- 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: ask a doctor
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Other Information
- do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
- store at room temperature 68-77°F (20°-25°C)
- see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients
Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum
Questions Or Comments?
Call 1-866-923-4914
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Pdp (68071 5305 1)
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