Active Ingredient
Hydrocortisone 1%
Hydrocortisone Cream
FDA Label NDC 68016-529
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Hydrocortisone (NDC 68016-529). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, when using this product, stop using this product and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Keep Out Of Reach Of Children
If Swallowed, get medical help or contact a Poison Control Center Immediately.
Uses
For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to
- Eczema
- Insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine, genital 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 the treatment of diaper rash, consult a doctor
- For external genital itching, if you have a vaginal discharge, consult a doctor
When Using This Product
- Avoid contact with the eyes.
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Using This Product And Ask A Doctor If
- Conditions worsen
- Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Directions
Adults and children 2 years and older
- Apply to affected area not mroe than 3 to 4 times daily.
- Do not use
- Consult a doctor
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Children under 12 years of age with external anal itching; consult a doctor.
Children under 2 years of age
For External and Anal Itching
Other Information
Store at controlled room temperature 20°-25°C (68°-77°F)
This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10® Aloe
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue
Wayne, PA. 19087
Product of PRC
Inactive Ingredients
Aloe Barbadensis leaf juice, Cetostearyl alcohol, Edtate disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Monostearate, White Petrolatum
Questions
Call 1-866-923-4914
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
* Please review the disclaimer below.
